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Irinotecan (Conventional)

Pronunciation

Pronunciation

(eye rye no TEE kan con VEN sha nal)

Index Terms

  • Camptothecin-11
  • Conventional Irinotecan
  • CPT-11
  • Irinotecan HCl
  • Irinotecan Hydrochloride

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Intravenous, as hydrochloride:

Camptosar: 40 mg/2 mL (2 mL); 100 mg/5 mL (5 mL); 300 mg/15 mL (15 mL)

Generic: 40 mg/2 mL (2 mL); 100 mg/5 mL (5 mL); 500 mg/25 mL (25 mL)

Solution, Intravenous, as hydrochloride [preservative free]:

Generic: 40 mg/2 mL (2 mL); 100 mg/5 mL (5 mL)

Brand Names: U.S.

  • Camptosar

Pharmacologic Category

  • Antineoplastic Agent, Camptothecin
  • Antineoplastic Agent, Topoisomerase I Inhibitor

Pharmacology

Irinotecan and its active metabolite (SN-38) bind reversibly to topoisomerase I-DNA complex preventing religation of the cleaved DNA strand. This results in the accumulation of cleavable complexes and double-strand DNA breaks. As mammalian cells cannot efficiently repair these breaks, cell death consistent with S-phase cell cycle specificity occurs, leading to termination of cellular replication.

Distribution

Children and Adolescents: ~37 L/m2 (range: 15.2-77 L/m2) (Ma, 2000); distributes to pleural fluid, sweat, and saliva

Adults: 33-150 L/m2

Metabolism

Primarily hepatic to SN-38 (active metabolite) by carboxylesterase enzymes; may also undergo CYP3A4-mediated metabolism to inactive metabolites (one of which may be hydrolyzed to release SN-38). SN-38 undergoes conjugation by UDP-glucuronosyl transferase 1A1 (UGT1A1) to form a glucuronide metabolite. SN-38 is increased by UGT1A1*28 polymorphism (10% of North Americans are homozygous for UGT1A1*28 allele).

Excretion

Urine: Irinotecan (11% to 20%), metabolites (SN-38 <1%, SN-38 glucuronide, 3%)

Time to Peak

Irinotecan: Oral: Children and Adolescents: 3 hours (Wagner 2010a)

SN-38: Following 90-minute infusion: ~1 hour

Half-Life Elimination

Children and Adolescents (Ma, 2000): Irinotecan: 2.66 hours (range: 1.82-4.47 hours); SN-38 (active metabolite): 1.58 hours (range: 0.29-8.28 hours)

Adults: Irinotecan: 6 to 12 hours; SN-38: ~10 to 20 hours

Protein Binding

Plasma: Predominantly albumin; Irinotecan: 30% to 68%, SN-38 (active metabolite): ~95%

Special Populations: Hepatic Function Impairment

Cl of irinotecan is decreased and exposure to the active metabolite (SN-38) is increased proportional to the degree of hepatic impairment.

Use: Labeled Indications

Colorectal cancer, metastatic: Treatment of metastatic carcinoma of the colon or rectum

Use: Unlabeled

Central nervous system tumors (recurrent glioblastoma), cervical cancer (recurrent or metastatic), esophageal cancer, Ewing’s sarcoma (recurrent or progressive), gastric cancer (metastatic or locally advanced), non-small cell lung cancer (advanced), ovarian cancer (recurrent), pancreatic cancer (advanced), rhabdomyosarcoma (relapsed/refractory), small cell lung cancer (extensive stage)

Contraindications

Hypersensitivity to irinotecan or any component of the formulation

Dosing: Adult

Note: A reduction in the starting dose by one dose level should be considered for prior pelvic/abdominal radiotherapy, performance status of 2, or known homozygosity for UGT1A1*28 allele (subsequent dosing/adjustments should be based on individual tolerance). Irinotecan (conventional) and irinotecan (liposomal) are NOT interchangeable. Dosing differs between formulations; verify intended product and dose prior to preparation and administration.

Premedications: Consider premedication of atropine 0.25 to 1 mg IV or SubQ in patients with cholinergic symptoms (eg, increased salivation, rhinitis, miosis, diaphoresis, abdominal cramping) or early-onset diarrhea. Irinotecan is associated with a moderate emetic potential; antiemetics are recommended to prevent nausea and vomiting (Basch 2011; Dupuis 2011; Roila 2010).

Colorectal cancer, metastatic (single-agent therapy): IV:

Weekly regimen: 125 mg/m2 over 90 minutes on days 1, 8, 15, and 22 of a 6-week treatment cycle (may adjust upward to 150 mg/m2 if tolerated)

Adjusted dose level -1: 100 mg/m2

Adjusted dose level -2: 75 mg/m2

Further adjust to 50 mg/m2 (in decrements of 25 to 50 mg/m2) if needed

Once-every-3-week regimen: 350 mg/m2 over 90 minutes, once every 3 weeks

Adjusted dose level -1: 300 mg/m2

Adjusted dose level -2: 250 mg/m2

Further adjust to 200 mg/m2 (in decrements of 25 to 50 mg/m2) if needed

Colorectal cancer, metastatic (in combination with fluorouracil and leucovorin): IV: Six-week (42-day) cycle:

Regimen 1: 125 mg/m2 over 90 minutes on days 1, 8, 15, and 22; to be given in combination with bolus leucovorin and fluorouracil (leucovorin administered immediately following irinotecan; fluorouracil immediately following leucovorin)

Adjusted dose level -1: 100 mg/m2

Adjusted dose level -2: 75 mg/m2

Further adjust if needed in decrements of ~20%

Regimen 2: 180 mg/m2 over 90 minutes on days 1, 15, and 29; to be given in combination with infusional leucovorin and bolus/infusion fluorouracil (leucovorin administered immediately following irinotecan; fluorouracil immediately following leucovorin)

Adjusted dose level -1: 150 mg/m2

Adjusted dose level -2: 120 mg/m2

Further adjust if needed in decrements of ~20%

Colorectal cancer, metastatic (off-label dosing): IV: FOLFOXIRI regimen: 165 mg/m2 over 1 hour once every 2 weeks (in combination with oxaliplatin, leucovorin, and fluorouracil) (Falcone 2007)

Cervical cancer, recurrent or metastatic (off-label use): IV: 125 mg/m2 over 90 minutes once weekly for 4 consecutive weeks followed by a 2-week rest during each 6 week treatment cycle (Verschraegen 1997)

CNS tumor, recurrent glioblastoma (off-label use): IV: 125 mg/m2 over 90 minutes once every 2 weeks (in combination with bevacizumab). NOTE: In patients taking concurrent antiepileptic enzyme-inducing medications irinotecan dose was increased to 340 mg/m2 (Friedman 2009; Vredenburgh 2007).

Esophageal cancer, metastatic or locally advanced (off-label use): IV: 65 mg/m2 over 90 minutes days 1, 8, 15, and 22 of a 6-week treatment cycle (in combination with cisplatin) (Ajani 2002; Ilson 1999) or 180 mg/m2 over 90 minutes every 2 weeks (in combination with leucovorin and fluorouracil) (Guimbaud 2014) or 250 mg/m2 every 3 weeks (in combination with capecitabine) (Leary 2009; Moehler 2010)

Ewing sarcoma, recurrent or progressive (off-label use): IV: 20 mg/m2 days 1 to 5 and days 8 to 12 every 3 weeks (in combination with temozolomide) (Casey 2009)

Gastric cancer, metastatic or locally advanced (off-label use): IV: 150 mg/m2 (as a single agent) on days 1 and 15 of a 4-week treatment cycle (Hironaka 2013) or 65 mg/m2 over 90 minutes days 1, 8, 15, and 22 of a 6-week treatment cycle (in combination with cisplatin) (Ajani 2002) or 70 mg/m2 over 90 minutes on days 1 and 15 of a 4-week treatment cycle (in combination with cisplatin) for up to 6 cycles (Park 2005) or 180 mg/m2 over 90 minutes every 2 weeks (in combination with leucovorin and fluorouracil) (Bouche 2004; Guimbaud 2014) or 250 mg/m2 every 3 weeks (in combination with capecitabine) (Moehler 2010)

Non-small cell lung cancer, advanced (off-label use): IV: 60 mg/m2 days 1, 8, and 15 every 4 weeks (in combination with cisplatin) (Ohe 2007)

Ovarian cancer, recurrent, platinum- and taxane-resistant (off-label use): IV: 100 mg/m2 days 1, 8, and 15 every 4 weeks (as a single-agent) for up to 6 cycles (Matsumoto 2006)

Pancreatic cancer, advanced (off-label use): IV: FOLFIRINOX regimen: 180 mg/m2 over 90 minutes every 2 weeks (in combination with oxaliplatin, leucovorin, and fluorouracil) (Conroy 2005; Conroy 2011)

Small cell lung cancer, extensive stage (off-label use): IV: 60 mg/m2 days 1, 8, and 15 every 4 weeks (in combination with cisplatin) (Noda 2002) or 65 mg/m2 days 1 and 8 every 3 weeks (in combination with cisplatin) (Hanna 2006) or 175 mg/m2 day 1 every 3 weeks (in combination with carboplatin) (Hermes 2008) or 50 mg/m2 days 1, 8 and 15 every 4 weeks (in combination with carboplatin) (Schmittel 2006)

Dosing: Geriatric

Weekly dosing schedule: No dosing adjustment is recommended

Every 3-week dosing colorectal cancer schedule: Recommended initial dose is 300 mg/m2/dose for patients ≥70 years

Dosing: Pediatric

See "Note" in adult dosing.

Ewing sarcoma, recurrent or progressive (off-label use): IV: Refer to adult dosing.

Rhabdomyosarcoma, relapsed/refractory (off-label use; Vassal 2007): IV:

Children <10 kg: 20 mg/kg once every 3 weeks

Children ≥10 kg and Adolescents: 600 mg/m2 once every 3 weeks

Dosing: Renal Impairment

Renal impairment: There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied); use with caution.

Dialysis: Use in patients with dialysis is not recommended by the manufacturer; however, literature suggests reducing weekly dose from 125 mg/m2 to 50 mg/m2 and administer after hemodialysis or on nondialysis days (Janus 2010).

Dosing: Hepatic Impairment

Manufacturer's labeling:

Liver metastases with normal hepatic function: No dosage adjustment necessary.

Bilirubin >ULN to ≤2 mg/dL: Consider reducing initial dose by one dose level

Bilirubin >2 mg/dL: Use is not recommended

Alternate recommendations: The following adjustments have also been recommended:

Bilirubin 1.5 to 3 mg/dL: Administer 75% of dose (Floyd 2006)

Bilirubin 1.51 to 3 times ULN: Reduce dose from 350 mg/m2 every 3 weeks to 200 mg/m2 every 3 weeks (Raymond 2002)

Dosing: Adjustment for Toxicity

It is recommended that new courses begin only after the granulocyte count recovers to ≥1,500/mm3, the platelet counts recover to ≥100,000/mm3, and treatment-related diarrhea has fully resolved. Depending on the patient's ability to tolerate therapy, doses should be adjusted in increments of 25 to 50 mg/m2. Treatment should be delayed 1 to 2 weeks to allow for recovery from treatment-related toxicities. If the patient has not recovered after a 2-week delay, consider discontinuing irinotecan. See tables.

Colorectal Cancer: Single-Agent Schedule: Recommended Dosage Modifications1

Toxicity NCI Grade2 (Value)

During a Cycle of Therapy

At Start of Subsequent Cycles of Therapy (After Adequate Recovery), Compared to Starting Dose in Previous Cycle1

Weekly

Weekly

Once Every 3 Weeks

1All dose modifications should be based on the worst preceding toxicity.

2National Cancer Institute Common Toxicity Criteria (version 1.0).

3Excludes alopecia, anorexia, asthenia.

No toxicity

Maintain dose level

↑ 25 mg/m2 up to a maximum dose of 150 mg/m2

Maintain dose level

Neutropenia

Grade 1 (1,500 to 1,999/mm3)

Maintain dose level

Maintain dose level

Maintain dose level

Grade 2 (1,000 to 1,499/mm3)

↓ 25 mg/m2

Maintain dose level

Maintain dose level

Grade 3 (500 to 999/mm3)

Omit dose until resolved to ≤ grade 2, then ↓ 25 mg/m2

↓ 25 mg/m2

↓ 50 mg/m2

Grade 4 (<500/mm3)

Omit dose until resolved to ≤ grade 2, then ↓ 50 mg/m2

↓ 50 mg/m2

↓ 50 mg/m2

Neutropenic Fever (grade 4 neutropenia and ≥ grade 2 fever)

Omit dose until resolved, then ↓ 50 mg/m2

↓ 50 mg/m2

↓ 50 mg/m2

Other Hematologic Toxicities

Dose modifications for leukopenia, thrombocytopenia, and anemia during a course of therapy and at the start of subsequent courses of therapy are also based on NCI toxicity criteria and are the same as recommended for neutropenia above.

Diarrhea

Grade 1 (2 to 3 stools/day > pretreatment)

Maintain dose level

Maintain dose level

Maintain dose level

Grade 2 (4 to 6 stools/day > pretreatment)

↓ 25 mg/m2

Maintain dose level

Maintain dose level

Grade 3 (7 to 9 stools/day > pretreatment)

Omit dose until resolved to ≤ grade 2, then ↓ 25 mg/m2

↓ 25 mg/m2

↓ 50 mg/m2

Grade 4 (≥10 stools/day > pretreatment)

Omit dose until resolved to ≤ grade 2, then ↓ 50 mg/m2

↓ 50 mg/m2

↓ 50 mg/m2

Other Nonhematologic Toxicities3

Grade 1

Maintain dose level

Maintain dose level

Maintain dose level

Grade 2

↓ 25 mg/m2

↓ 25 mg/m2

↓ 50 mg/m2

Grade 3

Omit dose until resolved to ≤ grade 2, then ↓ 25 mg/m2

↓ 25 mg/m2

↓ 50 mg/m2

Grade 4

Omit dose until resolved to ≤ grade 2, then ↓ 50 mg/m2

↓ 50 mg/m2

↓ 50 mg/m2

Table has been converted to the following text.

Colorectal Cancer: Single-Agent Schedules: Dosing Adjustment for Toxicities

Dosage modifications are based on NCI Common Toxicity Criteria grade (value). Note: All dose modifications should be based on the worst preceding toxicity.

NCI Grade (Value): No toxicity

• Weekly schedule:

– During a course of therapy: Maintain dose level.

– At the start of the next courses of therapy (after adequate recovery), compared to the starting dose in the previous courses: Increase by 25 mg/m2 up to a maximum of 150 mg/m2.

• Once-every-3-weeks schedule:

– At the start of the next courses of therapy (after adequate recovery), compared to the starting dose in the previous courses: Maintain dose level.

Neutropenia: NCI Grade 1 (1,500 to 1,999/mm3):

• Weekly schedule:

– During a course of therapy: Maintain dose level.

– At the start of the next courses of therapy (after adequate recovery), compared to the starting dose in the previous courses: Maintain dose level.

• Once-every-3-weeks schedule:

– At the start of the next courses of therapy (after adequate recovery), compared to the starting dose in the previous courses: Maintain dose level.

Neutropenia: NCI Grade 2 (1,000 to 1,499/mm3):

• Weekly schedule:

– During a course of therapy: Decrease by 25 mg/m2.

– At the start of the next courses of therapy (after adequate recovery), compared to the starting dose in the previous courses: Maintain dose level.

• Once-every-3-weeks schedule:

– At the start of the next courses of therapy (after adequate recovery), compared to the starting dose in the previous courses: Maintain dose level.

Neutropenia: NCI Grade 3 (500 to 999/mm3):

• Weekly schedule:

– During a course of therapy: Omit dose until resolved to ≤ Grade 2, then decrease by 25 mg/m2.

– At the start of the next courses of therapy (after adequate recovery), compared to the starting dose in the previous courses: Decrease by 25 mg/m2.

• Once-every-3-weeks schedule:

– At the start of the next courses of therapy (after adequate recovery), compared to the starting dose in the previous courses: Decrease by 50 mg/m2.

Neutropenia: NCI Grade 4 (<500/mm3):

• Weekly schedule:

– During a course of therapy: Omit dose until resolved to ≤ Grade 2, then decrease by 50 mg/m2.

– At the start of the next courses of therapy (after adequate recovery), compared to the starting dose in the previous courses: Decrease by 50 mg/m2.

• Once-every-3-weeks schedule:

– At the start of the next courses of therapy (after adequate recovery), compared to the starting dose in the previous courses: Decrease by 50 mg/m2.

Neutropenic fever (Grade 4 neutropenia and ≥ Grade 2 fever):

• Weekly schedule:

– During a course of therapy: Omit dose until resolved, then decrease by 50 mg/m2.

– At the start of the next courses of therapy (after adequate recovery), compared to the starting dose in the previous courses: Decrease by 50 mg/m2.

• Once-every-3-weeks schedule:

– At the start of the next courses of therapy (after adequate recovery), compared to the starting dose in the previous courses: Decrease by 50 mg/m2.

Other hematologic toxicities:

• Dose modifications for leukopenia, thrombocytopenia, and anemia during a course of therapy and at the start of subsequent courses of therapy are also based on NCI toxicity criteria and are the same as recommended for neutropenia above.

Diarrhea: NCI Grade 1 (2 to 3 stools/day > pretreatment):

• Weekly schedule:

– During a course of therapy: Maintain dose level.

– At the start of the next courses of therapy (after adequate recovery), compared to the starting dose in the previous courses: Maintain dose level.

• Once-every-3-weeks schedule:

– At the start of the next courses of therapy (after adequate recovery), compared to the starting dose in the previous courses: Maintain dose level.

Diarrhea: NCI Grade 2 (4 to 6 stools/day > pretreatment):

• Weekly schedule:

– During a course of therapy: Decrease by 25 mg/m2.

– At the start of the next courses of therapy (after adequate recovery), compared to the starting dose in the previous courses: Maintain dose level.

• Once-every-3-weeks schedule:

– At the start of the next courses of therapy (after adequate recovery), compared to the starting dose in the previous courses: Maintain dose level.

Diarrhea: NCI Grade 3 (7 to 9 stools/day > pretreatment):

• Weekly schedule:

– During a course of therapy: Omit dose until resolved to ≤ grade 2, then decrease by 25 mg/m2.

– At the start of the next courses of therapy (after adequate recovery), compared to the starting dose in the previous courses: Decrease by 25 mg/m2.

• Once-every-3-weeks schedule:

– At the start of the next courses of therapy (after adequate recovery), compared to the starting dose in the previous courses: Decrease by 50 mg/m2.

Diarrhea: NCI Grade 4 (≥10 stools/day > pretreatment):

• Weekly schedule:

– During a course of therapy: Omit dose until resolved to ≤ grade 2, then decrease by 50 mg/m2.

– At the start of the next courses of therapy (after adequate recovery), compared to the starting dose in the previous courses: Decrease by 50 mg/m2.

• Once-every-3-weeks schedule:

– At the start of the next courses of therapy (after adequate recovery), compared to the starting dose in the previous courses: Decrease by 50 mg/m2.

Other Nonhematologic Toxicities (excludes alopecia, anorexia, asthenia)

NCI Grade 1:

• Weekly schedule:

– During a course of therapy: Maintain dose level.

– At the start of the next courses of therapy (after adequate recovery), compared to the starting dose in the previous courses: Maintain dose level.

• Once-every-3-weeks schedule:

– At the start of the next courses of therapy (after adequate recovery), compared to the starting dose in the previous courses: Maintain dose level.

NCI Grade 2:

• Weekly schedule:

– During a course of therapy: Decrease by 25 mg/m2.

– At the start of the next courses of therapy (after adequate recovery), compared to the starting dose in the previous courses: Decrease by 25 mg/m2.

• Once-every-3-weeks schedule:

– At the start of the next courses of therapy (after adequate recovery), compared to the starting dose in the previous courses: Decrease by 50 mg/m2.

NCI Grade 3:

• Weekly schedule:

– During a course of therapy: Omit dose until resolved to ≤ grade 2, then decrease by 25 mg/m2.

– At the start of the next courses of therapy (after adequate recovery), compared to the starting dose in the previous courses: Decrease by 25 mg/m2.

• Once-every-3-weeks schedule:

– At the start of the next courses of therapy (after adequate recovery), compared to the starting dose in the previous courses: Decrease by 50 mg/m2.

NCI Grade 4:

• Weekly schedule:

– During a course of therapy: Omit dose until resolved to≤ grade 2, then decrease by 50 mg/m2.

– At the start of the next courses of therapy (after adequate recovery), compared to the starting dose in the previous courses: Decrease by 50 mg/m2.

• Once-every-3-weeks schedule:

– At the start of the next courses of therapy (after adequate recovery), compared to the starting dose in the previous courses: Decrease by 50 mg/m2.

Colorectal Cancer: Combination Schedules: Recommended Dosage Modifications1

Toxicity NCI2 Grade (Value)

During a Cycle of Therapy

At the Start of Subsequent Cycles of Therapy (After Adequate Recovery), Compared to the Starting Dose in the Previous Cycle1

1All dose modifications should be based on the worst preceding toxicity.

2National Cancer Institute Common Toxicity Criteria (version 1.0).

3Excludes alopecia, anorexia, asthenia.

No toxicity

Maintain dose level

Maintain dose level

Neutropenia

Grade 1 (1,500 to 1,999/mm3)

Maintain dose level

Maintain dose level

Grade 2 (1,000 to 1,499/mm3)

↓ 1 dose level

Maintain dose level

Grade 3 (500 to 999/mm3)

Omit dose until resolved to ≤ grade 2, then ↓ 1 dose level

↓ 1 dose level

Grade 4 (<500/mm3)

Omit dose until resolved to ≤ grade 2, then ↓ 2 dose levels

↓ 2 dose levels

Neutropenic Fever (grade 4 neutropenia and ≥ grade 2 fever)

Omit dose until resolved, then ↓ 2 dose levels

Other Hematologic Toxicities

Dose modifications for leukopenia or thrombocytopenia during a course of therapy and at the start of subsequent courses of therapy are also based on NCI toxicity criteria and are the same as recommended for neutropenia above.

Diarrhea

Grade 1 (2 to 3 stools/day > pretreatment)

Delay dose until resolved to baseline, then give same dose

Maintain dose level

Grade 2 (4 to 6 stools/day > pretreatment)

Omit dose until resolved to baseline, then ↓ 1 dose level

Maintain dose level

Grade 3 (7 to 9 stools/day > pretreatment)

Omit dose until resolved to baseline, then ↓ by 1 dose level

↓ 1 dose level

Grade 4 (≥10 stools/day > pretreatment)

Omit dose until resolved to baseline, then ↓ 2 dose levels

↓ 2 dose levels

Other Nonhematologic Toxicities3

Grade 1

Maintain dose level

Maintain dose level

Grade 2

Omit dose until resolved to ≤ grade 1, then ↓ 1 dose level

Maintain dose level

Grade 3

Omit dose until resolved to ≤ grade 2, then ↓ 1 dose level

↓ 1 dose level

Grade 4

Omit dose until resolved to ≤ grade 2, then ↓ 2 dose levels

↓ 2 dose levels

Mucositis and/or stomatitis

Decrease only 5-FU, not irinotecan

Decrease only 5-FU, not irinotecan

Table has been converted to the following text.

Colorectal Cancer: Combination Schedules: Dosing Adjustment for Toxicities

Dosage modifications are based on NCI Common Toxicity Criteria grade (value). Note: All dose modifications should be based on the worst preceding toxicities.

NCI Grade (Value): No toxicity

• During a cycle of therapy: Maintain dose level.

• At the start of subsequent cycles of therapy (after adequate recovery), compared to the starting dose in the previous cycle: Maintain dose level.

Neutropenia: NCI Grade 1 (1,500 to 1,999/mm3):

• During a cycle of therapy: Maintain dose level.

• At the start of subsequent cycles of therapy (after adequate recovery), compared to the starting dose in the previous cycles: Maintain dose level.

Neutropenia: NCI Grade 2 (1,000 to 1,499/mm3):

• During a cycle of therapy: Decrease by 1 dose level.

• At the start of subsequent cycles of therapy (after adequate recovery), compared to the starting dose in the previous cycles: Maintain dose level.

Neutropenia: NCI Grade 3 (500 to 999/mm3):

• During a cycle of therapy: Omit dose until resolved to ≤ grade 2, then decrease by 1 dose level.

• At the start of subsequent cycles of therapy (after adequate recovery), compared to the starting dose in the previous cycles: Decrease by 1 dose level.

Neutropenia: NCI Grade 4 (<500/mm3):

• During a cycle of therapy: Omit dose until resolved to ≤ grade 2, then decrease by 2 dose levels.

• At the start of subsequent cycles of therapy (after adequate recovery), compared to the starting dose in the previous cycles: Decrease by 2 dose levels.

Neutropenic fever (grade4 neutropenia and ≥ grade 2 fever):

• During a cycle of therapy: Omit dose until resolved, then decrease by 2 dose levels.

Other hematologic toxicities:

• Dose modifications during a cycle of therapy and at the start of subsequent cycles of therapy are also based on NCI toxicity criteria and are the same as recommended for neutropenia above.

Diarrhea: NCI Grade 1 (2 to 3 stools/day > pretreatment):

• During a cycle of therapy: Delay dose until resolved to baseline, then give same dose.

• At the start of subsequent cycles of therapy (after adequate recovery), compared to the starting dose in the previous cycles: Maintain dose level.

Diarrhea: NCI Grade 2 (4 to 6 stools/day > pretreatment):

• During a cycle of therapy: Omit dose until resolved to baseline, then decrease by 1 dose level.

• At the start of subsequent cycles of therapy (after adequate recovery), compared to the starting dose in the previous cycles: Maintain dose level.

Diarrhea: NCI Grade 3 (7 to 9 stools/day > pretreatment):

• During a cycle of therapy: Omit dose until resolved to baseline, then decrease by 1 dose level.

• At the start of subsequent cycles of therapy (after adequate recovery), compared to the starting dose in the previous cycles: Decrease by 1 dose level.

Diarrhea: NCI Grade 4 (≥10 stools/day > pretreatment):

• During a cycle of therapy: Omit dose until resolved to baseline, then decrease by 2 dose levels.

• At the start of subsequent cycles of therapy (after adequate recovery), compared to the starting dose in the previous cycles: Decrease by 2 dose levels.

Other Nonhematologic Toxicities (excludes alopecia, anorexia, asthenia)

NCI Grade 1:

• During a cycle of therapy: Maintain dose level.

• At the start of subsequent cycles of therapy (after adequate recovery), compared to the starting dose in the previous cycles: Maintain dose level.

NCI Grade 2:

• During a cycle of therapy: Omit dose until resolved to ≤ grade 1, then decrease by 1 dose level.

• At the start of subsequent cycles of therapy (after adequate recovery), compared to the starting dose in the previous cycles: Maintain dose level.

NCI Grade 3:

• During a cycle of therapy: Omit dose until resolved to ≤ grade 2, then decrease by 1 dose level.

• At the start of subsequent cycles of therapy (after adequate recovery), compared to the starting dose in the previous cycles: Decrease by 1 dose level.

NCI Grade 4:

• During a cycle of therapy: Omit dose until resolved to ≤ grade 2, then decrease by 2 dose levels.

• At the start of subsequent cycles of therapy (after adequate recovery), compared to the starting dose in the previous cycles: Decrease by 2 dose levels.

Mucositis/stomatitis:

• During a cycle of therapy: Decrease only 5-FU, not irinotecan.

• At the start of subsequent cycles of therapy (after adequate recovery), compared to the starting dose in the previous cycles: Decrease only 5-FU, not irinotecan.

Dosing: Obesity

ASCO Guidelines for appropriate chemotherapy dosing in obese adults with cancer: Utilize patient’s actual body weight (full weight) for calculation of body surface area- or weight-based dosing, particularly when the intent of therapy is curative; manage regimen-related toxicities in the same manner as for nonobese patients; if a dose reduction is utilized due to toxicity, consider resumption of full weight-based dosing with subsequent cycles, especially if cause of toxicity (eg, hepatic or renal impairment) is resolved (Griggs 2012).

Reconstitution

Hazardous agent; use appropriate precautions for handling and disposal (NIOSH 2014 [group 1]). Dilute in D5W (preferred) or NS to a final concentration of 0.12 to 2.8 mg/mL.

Administration

Administer by IV infusion, usually over 90 minutes. Irinotecan is associated with a moderate emetic potential (Basch 2011; Dupuis 2011; Roila 2010); premedication with dexamethasone and a 5-HT3 blocker is recommended 30 minutes prior to administration; prochlorperazine may be considered for subsequent use (if needed). Consider atropine 0.25 to 1 mg IV or SubQ as premedication for or treatment of cholinergic symptoms (eg, increased salivation, rhinitis, miosis, diaphoresis, abdominal cramping) or early onset diarrhea.

The recommended regimen to manage late diarrhea is loperamide 4 mg orally at onset of late diarrhea, followed by 2 mg every 2 hours (or 4 mg every 4 hours at night) until 12 hours have passed without a bowel movement. If diarrhea recurs, then repeat administration. Loperamide should not be used for more than 48 consecutive hours.

Hazardous agent; use appropriate precautions for handling and disposal (NIOSH 2014 [group 1]).

Dietary Considerations

Contains sorbitol; do not use in patients with hereditary fructose intolerance.

Compatibility

Stable in D5W, NS.

Y-site administration: Incompatible with gemcitabine, pemetrexed.

Storage

Store intact vials at 15°C to 30°C (59°F to 86°F). Protect from light; retain vials in original carton until use. Solutions diluted in NS may precipitate if refrigerated. Solutions diluted in D5W are stable for 24 hours at room temperature or 48 hours under refrigeration at 2°C to 8°C (36°F to 46°F), although the manufacturer recommends use within 24 hours if refrigerated, or within 4 to 12 hours (manufacturer dependent; refer to specific prescribing information) at room temperature (including infusion time) only if prepared under strict aseptic conditions (eg, laminar flow hood). Do not freeze. Undiluted commercially available injectable solution prepared in oral syringes is stable for 21 days under refrigeration (Wagner 2010).

Drug Interactions

Aprepitant: May increase the serum concentration of CYP3A4 Substrates. Monitor therapy

BCG (Intravesical): Immunosuppressants may diminish the therapeutic effect of BCG (Intravesical). Avoid combination

BCG (Intravesical): Myelosuppressive Agents may diminish the therapeutic effect of BCG (Intravesical). Avoid combination

Bosentan: May decrease the serum concentration of CYP3A4 Substrates. Monitor therapy

CloZAPine: Myelosuppressive Agents may enhance the adverse/toxic effect of CloZAPine. Specifically, the risk for neutropenia may be increased. Monitor therapy

Coccidioides immitis Skin Test: Immunosuppressants may diminish the diagnostic effect of Coccidioides immitis Skin Test. Monitor therapy

Conivaptan: May increase the serum concentration of CYP3A4 Substrates. Avoid combination

CYP3A4 Inducers (Moderate): May decrease the serum concentration of CYP3A4 Substrates. Monitor therapy

CYP3A4 Inducers (Strong): May decrease serum concentrations of the active metabolite(s) of Irinotecan Products. Specifically, serum concentrations of SN-38 may be reduced. CYP3A4 Inducers (Strong) may decrease the serum concentration of Irinotecan Products. Avoid combination

CYP3A4 Inhibitors (Moderate): May decrease the metabolism of CYP3A4 Substrates. Monitor therapy

CYP3A4 Inhibitors (Strong): May increase serum concentrations of the active metabolite(s) of Irinotecan Products. Specifically, serum concentrations of SN-38 may be increased. CYP3A4 Inhibitors (Strong) may increase the serum concentration of Irinotecan Products. Avoid combination

Dabrafenib: May decrease the serum concentration of CYP3A4 Substrates. Management: Seek alternatives to the CYP3A4 substrate when possible. If concomitant therapy cannot be avoided, monitor clinical effects of the substrate closely (particularly therapeutic effects). Consider therapy modification

Dasatinib: May increase the serum concentration of CYP3A4 Substrates. Monitor therapy

Deferasirox: May decrease the serum concentration of CYP3A4 Substrates. Monitor therapy

Deferiprone: Myelosuppressive Agents may enhance the neutropenic effect of Deferiprone. Avoid combination

Denosumab: May enhance the adverse/toxic effect of Immunosuppressants. Specifically, the risk for serious infections may be increased. Monitor therapy

Dipyrone: May enhance the adverse/toxic effect of Myelosuppressive Agents. Specifically, the risk for agranulocytosis and pancytopenia may be increased Avoid combination

Echinacea: May diminish the therapeutic effect of Immunosuppressants. Consider therapy modification

Fingolimod: Immunosuppressants may enhance the immunosuppressive effect of Fingolimod. Management: Avoid the concomitant use of fingolimod and other immunosuppressants when possible. If combined, monitor patients closely for additive immunosuppressant effects (eg, infections). Consider therapy modification

Fosaprepitant: May increase the serum concentration of CYP3A4 Substrates. Monitor therapy

Fusidic Acid (Systemic): May increase the serum concentration of CYP3A4 Substrates. Avoid combination

Idelalisib: May increase the serum concentration of CYP3A4 Substrates. Avoid combination

Ivacaftor: May increase the serum concentration of CYP3A4 Substrates. Monitor therapy

Leflunomide: Immunosuppressants may enhance the adverse/toxic effect of Leflunomide. Specifically, the risk for hematologic toxicity such as pancytopenia, agranulocytosis, and/or thrombocytopenia may be increased. Management: Consider not using a leflunomide loading dose in patients receiving other immunosuppressants. Patients receiving both leflunomide and another immunosuppressant should be monitored for bone marrow suppression at least monthly. Consider therapy modification

Lenograstim: Antineoplastic Agents may diminish the therapeutic effect of Lenograstim. Consider therapy modification

Luliconazole: May increase the serum concentration of CYP3A4 Substrates. Monitor therapy

Natalizumab: Immunosuppressants may enhance the adverse/toxic effect of Natalizumab. Specifically, the risk of concurrent infection may be increased. Avoid combination

Netupitant: May increase the serum concentration of CYP3A4 Substrates. Monitor therapy

Nivolumab: Immunosuppressants may diminish the therapeutic effect of Nivolumab. Consider therapy modification

Palbociclib: May increase the serum concentration of CYP3A4 Substrates. Monitor therapy

Palifermin: May enhance the adverse/toxic effect of Antineoplastic Agents. Specifically, the duration and severity of oral mucositis may be increased. Management: Do not administer palifermin within 24 hours before, during infusion of, or within 24 hours after administration of myelotoxic chemotherapy. Consider therapy modification

P-glycoprotein/ABCB1 Inducers: May decrease the serum concentration of P-glycoprotein/ABCB1 Substrates. P-glycoprotein inducers may also further limit the distribution of p-glycoprotein substrates to specific cells/tissues/organs where p-glycoprotein is present in large amounts (e.g., brain, T-lymphocytes, testes, etc.). Monitor therapy

P-glycoprotein/ABCB1 Inhibitors: May increase the serum concentration of P-glycoprotein/ABCB1 Substrates. P-glycoprotein inhibitors may also enhance the distribution of p-glycoprotein substrates to specific cells/tissues/organs where p-glycoprotein is present in large amounts (e.g., brain, T-lymphocytes, testes, etc.). Monitor therapy

Pimecrolimus: May enhance the adverse/toxic effect of Immunosuppressants. Avoid combination

Ranolazine: May increase the serum concentration of P-glycoprotein/ABCB1 Substrates. Monitor therapy

Roflumilast: May enhance the immunosuppressive effect of Immunosuppressants. Consider therapy modification

Siltuximab: May decrease the serum concentration of CYP3A4 Substrates. Monitor therapy

Simeprevir: May increase the serum concentration of CYP3A4 Substrates. Monitor therapy

Sipuleucel-T: Immunosuppressants may diminish the therapeutic effect of Sipuleucel-T. Monitor therapy

SORAfenib: May increase serum concentrations of the active metabolite(s) of Irinotecan Products. Specifically, concentrations of SN-38 may be increased. SORAfenib may increase the serum concentration of Irinotecan Products. Monitor therapy

St John's Wort: May decrease serum concentrations of the active metabolite(s) of Irinotecan Products. Specifically, concentrations of SN-38 may be reduced. St John's Wort may decrease the serum concentration of Irinotecan Products. Avoid combination

Stiripentol: May increase the serum concentration of CYP3A4 Substrates. Management: Use of stiripentol with CYP3A4 substrates that are considered to have a narrow therapeutic index should be avoided due to the increased risk for adverse effects and toxicity. Any CYP3A4 substrate used with stiripentol requires closer monitoring. Consider therapy modification

Tacrolimus (Topical): May enhance the adverse/toxic effect of Immunosuppressants. Avoid combination

Teriflunomide: May increase the serum concentration of OATP1B1/SLCO1B1 Substrates. Monitor therapy

Tocilizumab: May decrease the serum concentration of CYP3A4 Substrates. Monitor therapy

Tofacitinib: Immunosuppressants may enhance the immunosuppressive effect of Tofacitinib. Management: Concurrent use with antirheumatic doses of methotrexate or nonbiologic disease modifying antirheumatic drugs (DMARDs) is permitted, and this warning seems particularly focused on more potent immunosuppressants. Avoid combination

Trastuzumab: May enhance the neutropenic effect of Immunosuppressants. Monitor therapy

UGT1A1 Inhibitors: May increase serum concentrations of the active metabolite(s) of Irinotecan Products. Specifically, concentrations of SN-38 may be increased. UGT1A1 Inhibitors may increase the serum concentration of Irinotecan Products. Avoid combination

Vaccines (Inactivated): Immunosuppressants may diminish the therapeutic effect of Vaccines (Inactivated). Management: Vaccine efficacy may be reduced. Complete all age-appropriate vaccinations at least 2 weeks prior to starting an immunosuppressant. If vaccinated during immunosuppressant therapy, revaccinate at least 3 months after immunosuppressant discontinuation. Consider therapy modification

Vaccines (Live): Immunosuppressants may enhance the adverse/toxic effect of Vaccines (Live). Immunosuppressants may diminish the therapeutic effect of Vaccines (Live). Management: Avoid use of live organism vaccines with immunosuppressants; live-attenuated vaccines should not be given for at least 3 months after immunosuppressants. Avoid combination

Adverse Reactions

Frequency of adverse reactions reported for single-agent use of irinotecan only. In limited pediatric experience, dehydration (often associated with severe hypokalemia and hyponatremia) was among the most significant grade 3/4 adverse events, with a frequency up to 29%. In addition, grade 3/4 infection was reported in 24%.

>10%:

Cardiovascular: Vasodilatation (9% to 11%)

Central nervous system: Cholinergic syndrome (47%; includes diaphoresis, flushing, increased peristalsis, lacrimation, miosis, rhinitis, sialorrhea), pain (23% to 24%), dizziness (15% to 21%), insomnia (19%), headache (17%), chills (14%)

Dermatologic: Alopecia (46% to 72%), diaphoresis (16%), skin rash (13% to 14%)

Endocrine & metabolic: Weight loss (30%), dehydration (15%)

Gastrointestinal: Diarrhea (late: 83% to 88%, grades 3/4: 14% to 31%; early: 43% to 51%, grades 3/4: 7% to 22%), nausea (70% to 86%), abdominal pain (57% to 68%), vomiting (62% to 67%), abdominal cramps (57%), anorexia (44% to 55%), constipation (30% to 32%), mucositis (30%), flatulence (12%), stomatitis (12%)

Hematologic & oncologic: Anemia (60% to 97%; grades 3/4: 5% to 7%), leukopenia (63% to 96%, grades 3/4: 14% to 28%), thrombocytopenia (96%, grades 3/4: 1% to 4%), neutropenia (30% to 96%; grades 3/4: 14% to 31%)

Hepatic: Increased serum bilirubin (84%), increased serum alkaline phosphatase (13%)

Infection: Infection (14%)

Neuromuscular & skeletal: Weakness (69% to 76%), back pain (14%)

Respiratory: Dyspnea (22%), cough (17% to 20%), rhinitis (16%)

Miscellaneous: Fever (44% to 45%)

1% to 10%:

Cardiovascular: Edema (10%), hypotension (6%), thromboembolism (5%)

Central nervous system: Drowsiness (9%), confusion (3%)

Gastrointestinal: Abdominal fullness (10%), dyspepsia (10%)

Hematologic & oncologic: Febrile neutropenia (grades 3/4: 2% to 6%), hemorrhage (grades 3/4: 1% to 5%), neutropenic infection (grades 3/4: 1% to 2%)

Hepatic: Increased serum AST (10%), ascites (grades 3/4: ≤9%), jaundice (grades 3/4: ≤9%)

Respiratory: Pneumonia (4%)

<1% (Limited to important or life-threatening): Acute renal failure, anaphylactoid reaction, anaphylaxis, angina pectoris, arterial thrombosis, bradycardia, cardiac arrhythmia, cerebral infarction, cerebrovascular accident, circulatory shock, colitis, embolism, gastrointestinal hemorrhage, gastrointestinal obstruction, hepatomegaly, hyperglycemia, hypersensitivity reaction, hyponatremia, immune thrombocytopenia, increased amylase, increased serum ALT, increased serum lipase, interstitial pulmonary disease, intestinal obstruction, intestinal perforation, ischemic colitis, ischemic heart disease, lymphocytopenia, megacolon, myocardial infarction, pancreatitis, paresthesia, peripheral vascular disease, pulmonary embolism; pulmonary toxicity (includes dyspnea, fever, reticulonodular infiltrates on chest x-ray), renal insufficiency, thrombophlebitis, thrombosis, typhlitis (including neutropenic typhlitis), ulcerative colitis

ALERT: U.S. Boxed Warning

Diarrhea:

Early and late forms of diarrhea may occur. Early diarrhea may be accompanied by cholinergic symptoms that may be prevented or ameliorated by atropine. Late diarrhea can be life-threatening and should be treated promptly with loperamide. Monitor patients with diarrhea and give fluid and electrolytes as needed. Institute antibiotic therapy if patients develop ileus, fever, or severe neutropenia. Interrupt irinotecan and reduce subsequent doses if severe diarrhea occurs.

Bone marrow suppression:

Severe myelosuppression may occur.

Warnings/Precautions

Concerns related to adverse effects:

• Bone marrow suppression: [US Boxed Warning]: May cause severe myelosuppression. Deaths due to sepsis following severe neutropenia have been reported. Complications due to neutropenia should be promptly managed with antibiotics. Therapy should be temporarily withheld if neutropenic fever occurs or if the absolute neutrophil count is <1,000/mm3; reduce the dose upon recovery to an absolute neutrophil count ≥1,000/mm3. Patients who have previously received pelvic/abdominal radiation therapy have an increased risk of severe bone marrow suppression; the incidence of grade 3 or 4 neutropenia was higher in patients receiving weekly irinotecan who have previously received pelvic/abdominal radiation therapy. Concurrent radiation therapy is not recommended with irinotecan (based on limited data).

• Diarrhea: [US Boxed Warning]: Severe diarrhea may be dose-limiting and potentially fatal; early-onset and late-onset diarrhea may occur. Early diarrhea occurs during or within 24 hours of receiving irinotecan and is characterized by cholinergic symptoms; may be prevented or treated with atropine. Late diarrhea may be life-threatening and should be promptly treated with loperamide. Antibiotics may be necessary if patient develops ileus, fever, or severe neutropenia. Interrupt treatment and reduce subsequent doses for severe diarrhea. Early diarrhea is generally transient and rarely severe; cholinergic symptoms may include increased salivation, rhinitis, miosis, diaphoresis, flushing, abdominal cramping, and lacrimation; bradycardia may also occur. Cholinergic symptoms may occur more frequently with higher irinotecan doses. Late diarrhea occurs more than 24 hours after treatment, which may lead to dehydration, electrolyte imbalance, or sepsis. Late diarrhea may be complicated by colitis, ulceration, bleeding, ileus, obstruction, or infection; cases of megacolon and intestinal perforation have been reported. The median time to onset for late diarrhea is 5 days with every 3 week irinotecan dosing and 11 days with weekly dosing. Advise patients to have loperamide readily available for the treatment of late diarrhea. Patients with diarrhea should be carefully monitored and treated promptly; may require fluid and electrolyte therapy. Bowel function should be returned to baseline for at least 24 hours prior to resumption of weekly irinotecan dosing. Avoid diuretics and laxatives in patients experiencing diarrhea.

• Extravasation: Irinotecan is an irritant. Avoid extravasation; if extravasation occurs, the manufacturer recommends flushing the external site with sterile water and applying ice.

• Gastrointestinal toxicity: Irinotecan is associated with a moderate emetic potential; antiemetics are recommended to prevent nausea and vomiting (Basch 2011; Dupuis 2011; Roila 2010).

• Hypersensitivity reactions: Severe hypersensitivity reactions (including anaphylaxis) have occurred. Monitor closely; discontinue therapy if hypersensitivity occurs.

• Pulmonary toxicity: Fatal cases of interstitial pulmonary disease (IPD)-like events have been reported with single-agent and combination therapy. Risk factors for pulmonary toxicity include preexisting lung disease, use of pulmonary toxic medications, radiation therapy, and colony-stimulating factors. Patients with risk factors should be monitored for respiratory symptoms before and during irinotecan treatment. Promptly evaluate progressive changes in baseline pulmonary symptoms or any new-onset pulmonary symptoms (eg, dyspnea, cough, fever). Discontinue all chemotherapy if IPD is diagnosed.

• Renal toxicity: Renal impairment and acute renal failure have been reported, possibly due to dehydration secondary to diarrhea. Use with caution in patients with renal impairment; not recommended in patients on dialysis.

• Thromboembolism: Thromboembolic events have been reported.

Disease-related concerns:

• Bowel obstruction: Patients with bowel obstruction should not be treated with irinotecan until resolution of obstruction.

• Hepatic impairment: Use with caution in patients with hepatic impairment; exposure to the active metabolite (SN-38) is increased; toxicities may be increased. Patients with even modest elevations in total serum bilirubin levels (1 to 2 mg/dL) have a significantly greater likelihood of experiencing first-course grade 3 or 4 neutropenia than those with bilirubin levels that were <1 mg/dL. Patients with abnormal glucuronidation of bilirubin, such as those with Gilbert's syndrome, may also be at greater risk of myelosuppression when receiving therapy with irinotecan. Use caution when treating patients with known hepatic dysfunction or hyperbilirubinemia; dosage adjustments should be considered.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information. CYP3A4 enzyme inducers may decrease exposure to irinotecan and SN-38 (active metabolite); enzyme inhibitors may increase exposure. For use in patients with CNS tumors (off-label use), selection of antiseizure medications that are not enzyme inducers is preferred.

Special populations:

• Elderly: Patients >65 years of age are at greater risk for early and late diarrhea. A dose reduction is recommended for patients ≥70 years of age receiving the every-3-week regimen.

• Patients homozygous/heterozygous for the UGT1A1*28 allele: Patients homozygous for the UGT1A1*28 allele are at increased risk of neutropenia; initial one-level dose reduction should be considered for both single-agent and combination regimens. Heterozygous carriers of the UGT1A1*28 allele may also be at increased neutropenic risk; however, most patients have tolerated normal starting doses. A test is available for clinical determination of UGT phenotype, although a dose reduction is already recommended in patients who have experienced toxicity.

• Pelvic/abdominal radiation recipients: Use with caution in patients who have previously received pelvic/abdominal radiation; may increase risk of severe myelosuppression.

• Performance status: Higher rates of hospitalization, neutropenic fever, thromboembolism, first-cycle discontinuation, and early mortality were observed in patients with a performance status of 2 than in patients with a performance status of 0 or 1.

Dosage form specific issues:

• Conventional vs liposomal formulation dosing: Irinotecan (conventional) and irinotecan (liposomal) are NOT interchangeable. Dosing differs between formulations; verify intended product and dose prior to preparation and administration.

• Sorbitol: Product contains sorbitol; do not use in patients with hereditary fructose intolerance.

Special handling:

• Hazardous agent: Use appropriate precautions for handling and disposal (NIOSH 2014 [group 1]).

Other warnings/precautions:

• Appropriate use: Except as part of a clinical trial, use in combination with the fluorouracil and leucovorin administered for 4 or 5 consecutive days every 4 weeks (“Mayo Clinic” regimen) is not recommended due to increased toxicity.

Monitoring Parameters

CBC with differential, platelet count, and hemoglobin with each dose; bilirubin, electrolytes (with severe diarrhea); bowel movements and hydration status; signs/symptoms of pulmonary toxicity or hypersensitivity reactions; monitor infusion site for signs of inflammation and avoid extravasation

A test is available for genotyping of UGT1A1; however, use of the test is not widely accepted and a dose reduction is already recommended in patients who have experienced toxicity.

Pregnancy Risk Factor

D

Pregnancy Considerations

Adverse events were observed in animal reproduction studies. Information related to the use of irinotecan (conventional) during pregnancy is limited (Cirillo 2012; Taylor 2009). May cause fetal harm if administered during pregnancy. Women of childbearing potential should avoid becoming pregnant while receiving treatment.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience insomnia, headache, mouth sores, nausea, vomiting, abdominal pain, lack of appetite, constipation, hair loss, back pain, sweating a lot, weight loss, fatigue, or flatulence. Have patient report immediately to prescriber diarrhea, signs of infection, signs of fluid and electrolyte problems (mood changes, confusion, muscle pain or weakness, abnormal heartbeat, severe dizziness or passing out, tachycardia, more thirst, seizures, loss of strength and energy, lack of appetite, urinary retention or change in the amount of urine produced, dry mouth, dry eyes, or nausea or vomiting), signs of kidney problems (urinary retention, hematuria, change in amount of urine passed, weight gain), severe loss of strength and energy, signs of bleeding (vomiting blood or vomit that looks like coffee grounds; coughing up blood; blood in the urine; black, red, or tarry stools; bleeding from the gums; abnormal vaginal bleeding; bruises without a reason or that get bigger; or any severe bleeding or persistent bleeding), signs of a severe pulmonary disorder (lung or breathing problems like difficulty breathing, shortness of breath, or a cough that is new or worse), severe dizziness, passing out, severe loss of strength and energy, redness or irritation of palms or soles of feet, or severe injection site burning, pain, edema, or redness (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

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