Pomalidomide (Monograph)

Brand name: Pomalyst
Drug class: Antineoplastic Agents
Chemical name: 4-Amino-2-(2,6-dioxo-3-piperidinyl)-1H-isoindole-1,3(2H)-dione
Molecular formula: C₁₃H₁₁N₃O₄
CAS number: 19171-19-8

Medically reviewed by Drugs.com on Apr 7, 2023. Written by ASHP.

Warning

Risk Evaluation and Mitigation Strategy (REMS):

FDA approved a REMS for pomalidomide to ensure that the benefits outweigh the risks. The REMS may apply to one or more preparations of pomalidomide and consists of the following: elements to assure safe use and implementation system. See https://www.accessdata.fda.gov/scripts/cder/rems/.

Warning

Potential risk of teratogenicity and fetotoxicity due to structural similarity to thalidomide, a known human teratogen that can cause severe, life-threatening birth defects if administered during pregnancy.
Contraindicated in pregnant women.
In females of reproductive potential, pregnancy must be excluded prior to treatment initiation with 2 negative pregnancy tests, and pregnancy must be prevented by abstinence or simultaneous use of 2 forms of reliable contraception. (See Fetal/Neonatal Morbidity and Mortality under Cautions.)
Available only through a restricted distribution program. (See REMS under Dosage and Administration)

Increased risk of venous thromboembolism (e.g., DVT, PE) in patients with multiple myeloma. (See Thromboembolic Events under Cautions.)
Thromboprophylaxis is recommended.

Introduction

Biologic response modifier; thalidomide analog with immunomodulatory, antineoplastic, and antiangiogenic activity.

Uses for Pomalidomide

Multiple Myeloma

Treatment of multiple myeloma in patients who have received ≥2 prior therapies including a proteasome inhibitor and lenalidomide and demonstrated disease progression during or ≤60 days following completion of their last therapy (designated an orphan drug by FDA for use in multiple myeloma).

Efficacy determined based on 2 open-label studies in patients with relapsed or refractory multiple myeloma.

Kaposi Sarcoma

Treatment of Kaposi sarcoma in adult patients with acquired immunodeficiency syndrome (AIDS)-related Kaposi sarcoma after failure of highly active antiretroviral therapy (HAART).

Treatment of Kaposi sarcoma in adult patients who are HIV-negative.

Efficacy determined based on overall response rate in a single-arm, single-center, open-label study in patients with Kaposi sarcoma. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trials.

Designated an orphan drug by FDA for use in Kaposi sarcoma.

Pomalidomide Dosage and Administration

General

Pretreatment Screening

Tests to exclude pregnancy must be performed within 10–14 days and again within 24 hours immediately prior to treatment initiation.
Multiple myeloma: Do not begin a new treatment cycle until absolute neutrophil count (ANC) ≥500/mm³ and platelet count ≥50,000/mm³.
Kaposi sarcoma: Do not begin a new treatment cycle until ANC ≥1000/mm³ and platelet count ≥75,000/mm³.
Assess patients with multiple myeloma for risk factors for thromboembolism.

Patient Monitoring

Multiple myeloma: CBCs weekly during first 8 weeks of therapy and at least monthly thereafter.
Kaposi sarcoma: CBCs every 2 weeks for the first 3 months and monthly thereafter.
Pregnancy tests weekly during the first month of therapy, then every 2 or 4 weeks in females with irregular or regular menstrual cycles, respectively.
Development of second primary malignancies.
Liver function tests (LFTs) monthly.
Tumor lysis syndrome in patients with a high tumor burden.

Premedication and Prophylaxis

Thromboprophylaxis recommended. Carefully assess patients receiving pomalidomide for risk factors for thromboembolism; base decisions regarding use of thromboprophylaxis and appropriate thromboprophylaxis regimens (e.g., aspirin, anticoagulant) on patient’s risk.

Dispensing and Administration Precautions

Consult specialized references for procedures for proper handling and disposal of antineoplastics.
Avoid contact of capsule contents with skin or mucous membranes. If such contact occurs, wash affected areas of skin thoroughly with soap and water and rinse affected mucosa thoroughly with water.

REMS

Distribution of pomalidomide is restricted because it is an analog of thalidomide (a known human teratogen that can cause severe birth defects).
Must be obtained through a restricted distribution program (Pomalyst Risk Evaluation and Mitigation Strategy [REMS]) to help ensure that fetal exposure to pomalidomide does not occur. Clinicians, pharmacists, and patients must be registered in the program before they can prescribe, dispense, and receive pomalidomide; compliance with all terms outlined in the program is mandatory.
The Pomalyst REMS program controls access to pomalidomide; educates participants (clinicians, pharmacists, patients) about the risks associated with pomalidomide and the procedural requirements for safe use; and monitors compliance with the registration, education, and safety requirements of the program.
Prescribe and dispense no more than a 28-day supply at one time.
For additional details on program requirements, contact Bristol Myers Squibb at 888-423-5436 or visit [Web].

Administration

Oral Administration

Administer orally with water once daily.

Administer without regard to food.

Swallow capsules whole; do not break, chew, or open capsules.

Dosage

Adults

Multiple Myeloma

Oral

4 mg once daily on days 1–21 of each 28-day cycle; in combination with dexamethasone (40 mg once daily [or 20 mg in those >75 years of age] on days 1, 8, 15, and 22 of each 28-day cycle used in clinical trials)

Continue until disease progression or unacceptable toxicity occurs.

Dosage Modification for Toxicity in Patients with Multiple Myeloma

If adverse effects occur, temporarily interrupt therapy, reduce dosage, and/or permanently discontinue pomalidomide as described in Table 1.

If angioedema, anaphylaxis, grade 4 rash, skin exfoliation, bullae, or any other severe dermatologic reaction occurs, permanently discontinue pomalidomide. (See Cutaneous Reactions and also Hypersensitivity Reactions under Cautions.)

Table 1. Dosage Modification for Toxicity in Patients with Multiple Myeloma1
Adverse Reaction and Severity	Pomalidomide Dosage Modification (Starting Dosage = 4 mg daily on days 1–21 of each 28-day cycle)
Neutropenia
ANC <500/mm³	First occurrence: Withhold therapy and monitor CBCs weekly; when ANC ≥500/mm³, then resume at a dosage reduced by 1 mg
ANC <500/mm³	Subsequent occurrence: Withhold therapy until ANC ≥500/mm³, then resume at a dosage reduced by 1 mg
ANC <500/mm³	If a daily dosage of 1 mg is not tolerated, permanently discontinue pomalidomide
Febrile neutropenia (temperature of ≥38.5°C and ANC <1000/mm³)	Withhold therapy and monitor CBCs weekly; when ANC ≥500/mm³, then resume at a dosage reduced by 1 mg
Thrombocytopenia
Platelet count <25,000/mm³	First occurrence: Withhold therapy and monitor CBCs weekly; when platelet count ≥50,000/mm³, then resume at a dosage reduced by 1 mg
Platelet count <25,000/mm³	Subsequent occurrence: Withhold therapy until platelet count ≥50,000/mm³, then resume at a dosage reduced by 1 mg
Platelet count <25,000/mm³	If a daily dosage of 1 mg is not tolerated, permanently discontinue pomalidomide
Nonhematologic Toxicity
Grade 3 or 4 (excluding hypersensitivity or dermatologic reactions)	Withhold therapy; when toxicity resolves or improves to grade 2 or less, then resume at a dosage reduced by 1 mg

Kaposi Sarcoma

Oral

5 mg once daily on days 1–21 of each 28-day cycle.

Continue until disease progression or unacceptable toxicity.

Continue HV therapy with HAART in patients with AIDS-related Kaposi sarcoma.

Dosage Modification for Toxicity in Patients with Kaposi Sarcoma

If adverse effects occur, temporarily interrupt therapy, reduce dosage, and/or permanently discontinue pomalidomide as described in Table 2.

Table 2. Dosage Modification for Hematologic Adverse Effects in Patients with Kaposi Sarcoma1
Adverse Reaction and Severity	Pomalidomide Dosage Modification (Starting Dosage = 5 mg daily on days 1–21 of each 28-day cycle)
Neutropenia
ANC 500 to <1000/mm³	Day 1 of cycle: Withhold therapy; when ANC ≥1000/mm³, resume at same dosage
ANC 500 to <1000/mm³	During cycle: Continue current dosage
ANC <500/mm³	Withhold therapy; when ANC ≥1000/mm³, resume at same dosage
Febrile neutropenia (ANC <1000/mm³ and single temperature of ≥38.3°C or sustained temperature of ≥38°C for >1 hour)	Withhold therapy; when ANC ≥1000/mm³, then resume at a dosage reduced by 1 mg
Febrile neutropenia (ANC <1000/mm³ and single temperature of ≥38.3°C or sustained temperature of ≥38°C for >1 hour)	If a daily dosage of 1 mg is not tolerated, permanently discontinue pomalidomide
Thrombocytopenia
Platelet count 25,000 to <50,000/mm³	Day 1 of cycle: Withhold therapy; when platelet count ≥50,000/mm³, resume at same dosage
Platelet count 25,000 to <50,000/mm³	During cycle: Continue current dosage
Platelet count <25,000/mm³	Permanently discontinue pomalidomide

Dosage Modification for Concomitant Use with CYP1A2 Inhibitors

Avoid concomitant use with potent CYP1A2 inhibitors. If concomitant use cannot be avoided, reduce dosage to 2 mg daily. (See Interactions.)

Special Populations

Hepatic Impairment

Initial dosage reduction is necessary in patients with hepatic impairment (see Tables 3 and 4).

Table 3. Initial Recommended Pomalidomide Dosage in Patients with Multiple Myeloma and Hepatic Impairment1
Severity	Dose
Mild (Child-Pugh class A)	3 mg once daily
Moderate (Child-Pugh class B)	3 mg once daily
Severe (Child-Pugh class C)	2 mg once daily

Table 4. Initial Recommended Pomalidomide Dosage in Patients with Kaposi Sarcoma and Hepatic Impairment1
Severity	Dose
Mild (Child-Pugh class A)	3 mg once daily
Moderate (Child-Pugh class B)	3 mg once daily
Severe (Child-Pugh class C)	3 mg once daily

Renal Impairment

In patients with multiple myeloma and severe renal impairment requiring dialysis: Reduce initial dosage to 3 mg daily.

In patients with Kaposi sarcoma and severe renal impairment requiring dialysis: Reduce initial dosage to 4 mg daily.

Administer pomalidomide after completion of hemodialysis.

Geriatric Patients

No pomalidomide dosage adjustment recommended.

Cautions for Pomalidomide

Contraindications

Pregnancy. (See Boxed Warning and see Fetal/Neonatal Morbidity and Mortality under Cautions.)
Known hypersensitivity (e.g., angioedema, anaphylaxis) to pomalidomide or any ingredient in the formulation.

Warnings/Precautions

Warnings

Fetal/Neonatal Morbidity and Mortality

May cause fetal harm; contraindicated in pregnant women. Teratogenicity demonstrated in animals; structurally similar to thalidomide, a known human teratogen associated with severe birth defects and fetal death. (See REMS under Dosage and Administration.)

Pregnancy must be prevented (even in females with a history of infertility) by simultaneous use of 2 forms of effective contraception for ≥4 weeks before, throughout, and for 4 weeks after therapy, including during dosage interruptions. Must include at least 1 highly effective contraceptive method (e.g., intrauterine device [IUD], hormonal contraceptive, tubal ligation, vasectomized partner); other method may be an effective barrier method (e.g., latex or synthetic condom, diaphragm, cervical cap). Mandatory contraception not required for females who have undergone hysterectomy or bilateral oophorectomy, who are postmenopausal and have had no menses for ≥24 consecutive months, or who practice continuous abstinence from heterosexual contact.

Pomalidomide distributes into semen; sexually mature males (including those who have undergone successful vasectomy) must use a latex or synthetic condom each time they have sexual contact with a woman of childbearing potential during and for up to 28 days after therapy. Men must not donate semen during and for 4 weeks after therapy.

Patients must not donate blood during and for ≥1 month after therapy because of potential for any pomalidomide present in blood to be transfused into a pregnant woman.

Obtain 2 negative pregnancy test reports prior to initiating therapy in women of childbearing potential; tests to exclude pregnancy must be performed within 10–14 days and again within 24 hours immediately prior to treatment initiation. Repeat pregnancy tests weekly during the first month of therapy, then every 2 or 4 weeks in women with irregular or regular menstrual cycles, respectively.

Provide pregnancy testing and counseling if a patient misses her period or has abnormalities in menstrual bleeding. Discontinue drug during evaluation.

If pregnancy occurs, immediately discontinue treatment and apprise of potential fetal hazard. Refer patient to obstetrician-gynecologist experienced in reproductive toxicity for further evaluation and counseling. Report any suspected fetal exposure to FDA MedWatch Program at 800-FDA-1088 and to manufacturer at 888-423-5436.

Thromboembolic Events

Increased risk of venous and arterial thromboembolism (e.g., DVT, PE, MI, stroke).

Thromboprophylaxis is recommended. Carefully assess patients receiving pomalidomide for risk factors for thromboembolism; base decisions regarding use of thromboprophylaxis and appropriate thromboprophylaxis regimens (e.g., aspirin, anticoagulant) on patient’s risk. Risk is increased in patients with known risk factors (e.g., history of thrombosis); minimize modifiable risk factors (e.g., hyperlipidemia, hypertension, smoking).

Other Warnings and Precautions

Treatment-related Mortality

Increased mortality reported in patients with multiple myeloma receiving pembrolizumab in combination with a thalidomide analog and dexamethasone.

Patients with multiple myeloma should not receive an anti-programmed death receptor-1 (anti-PD-1) or anti-programmed-death ligand-1 (anti-PD-L1) in combination with a thalidomide analog and dexamethasone outside of a clinical trial.

Hematologic Effects

Risk of severe (grade 3 or 4) neutropenia, anemia, and/or thrombocytopenia in patients with multiple myeloma receiving pomalidomide in combination with low-dose dexamethasone. In the pivotal Kaposi sarcoma trial, neutropenia was the most commonly reported grade 3 or 4 adverse reaction.

In patients with multiple myeloma, monitor CBCs weekly during first 8 weeks of therapy and at least monthly thereafter.

In patients with Kaposi sarcoma, monitor CBCs every 2 weeks for the first 3 months and monthly thereafter.

If hematologic toxicity occurs, interrupt therapy and/or reduce dosage. (See Dosage Modification for Toxicity in Patients with Multiple Myeloma and also see Dosage Modification for Toxicity in Patients with Kaposi Sarcoma under Dosage and Administration.)

Hepatotoxicity

Hepatic failure, sometimes fatal, reported. Monitor liver function tests (LFTs) monthly; withhold therapy and consider dosage reduction for increased LFTs. (See Dosage Modification for Toxicity in Patients with Multiple Myeloma and also see Dosage Modification for Toxicity in Patients with Kaposi Sarcoma under Dosage and Administration.)

Cutaneous Reactions

Severe, and potentially fatal, cases of cutaneous reactions (Stevens-Johnson syndrome [SJS], toxic epidermal necrolysis [TEN], and drug reaction with eosinophilia and systemic symptoms [DRESS]) reported.

If grade 2 or 3 skin rash occurs, consider withholding or discontinuing pomalidomide. If grade 4 rash, exfoliative or bullous rash, or other severe cutaneous reactions (SJS, TEN, or DRESS) occur, permanently discontinue drug. (See Advice to Patients.)

Dizziness and Confusion

Dizziness and confusion reported in patients receiving pomalidomide in combination with low-dose dexamethasone.

Advise patients to avoid situations where dizziness or confusional state may be a problem and avoid other medications that may cause dizziness or confusional state without adequate medical advice.

Neuropathy

Neuropathy (frequently peripheral neuropathy) reported in patients receiving pomalidomide in combination with low-dose dexamethasone. (See Advice to Patients.)

Development of Second Primary Malignancy

Acute myelogenous leukemia (AML) reported in patients receiving pomalidomide as investigational therapy.

Tumor Lysis Syndrome

Tumor lysis syndrome may occur.

Risk is increased in patients with a high tumor burden. Monitor such patients and institute appropriate precautions.

Hypersensitivity Reactions

Angioedema, anaphylaxis, and anaphylactic reactions reported. Permanently discontinue pomalidomide if angioedema or anaphylaxis occur.

Specific Populations

Pregnancy

Contraindicated for use during pregnancy. (See REMS under Dosage and Administration and also see Fetal/Neonatal Morbidity and Mortality under Cautions.)

Females of Reproductive Potential

May impair female fertility.

Lactation

Distributed into milk in rats; not known whether distributed into human milk. Discontinue breast-feeding during therapy.

Pediatric Use

Safety and efficacy not established in pediatric patients.

In 2 open-label studies evaluating pomalidomide in pediatric patients (4 to <17 years of age), no new safety concerns observed.

Geriatric Use

Multiple myeloma: No overall differences in efficacy in geriatric patients (≥65 years of age) compared with younger adults. Increased incidence of pneumonia compared with younger adults.

Kaposi sarcoma: Insufficient experience in patients ≥65 years of age to determine whether efficacy and safety are similar to those in younger adults. (See Geriatric Patients under Dosage and Administration.)

Hepatic Impairment

Primarily metabolized in the liver. Increased AUC in patients with hepatic impairment; dosage adjustment required. (See Hepatic Impairment under Dosage and Administration.)

Renal Impairment

Pharmacokinetics not significantly altered by moderate (Cl_cr 30 to <60 mL/minute) or severe (Cl_cr 15 to <30 mL/minute) renal impairment.

Increased AUC and adverse events in patients with severe renal impairment receiving dialysis. (See Renal Impairment under Dosage and Administration.)

Common Adverse Effects

Combination therapy with low-dose dexamethasone in patients with multiple myeloma (≥30%): Fatigue and asthenia, neutropenia, anemia, constipation, nausea, diarrhea, dyspnea, upper -respiratory tract infections, back pain, pyrexia.

Monotherapy in patients with Kaposi sarcoma (≥30%): Decreased ANC, decreased WBC, decreased hemoglobin concentrations, decreased platelet count, decreased serum phosphate concentrations, decreased serum albumin concentrations, decreased serum calcium concentrations, increased S_cr concentrations, increased serum glucose concentrations, increased serum ALT concentrations, rash, constipation, fatigue, nausea, diarrhea.

Drug Interactions

Metabolized primarily by CYP1A2 and CYP3A4.

Does not inhibit or induce CYP isoenzymes in vitro.

Substrate of P-glycoprotein (P-gp); does not inhibit or induce P-gp or other transporters in vitro.

Drugs Affecting Hepatic Microsomal Enzymes

Potent CYP1A2 inhibitors: Increased pomalidomide exposure. Avoid concomitant use. If concomitant use cannot be avoided, reduce pomalidomide dosage.

Potent CYP1A2 inducers: Possible decreased pomalidomide exposure.

CYP3A4 inhibitors or inducers: No clinically significant alterations in pomalidomide exposure.

Drugs Affecting Efflux Transport Systems

P-gp inhibitors: No clinically significant alterations in pomalidomide exposure.

Specific Drugs and Foods

Drug	Interaction	Comments
Carbamazepine	No significant decrease effect on pomalidomide exposure
Cigarette smoking	Decreased AUC of pomalidomide by 32% and increased peak plasma concentration by 14%; possible reduced efficacy
Ciprofloxacin	Possible increased pomalidomide exposure	Avoid concomitant use; if concomitant use cannot be avoided, reduce pomalidomide dosage
Dexamethasone	No substantial effect on pharmacokinetics of pomalidomide
Fluvoxamine	Increased systemic exposure to pomalidomide by 125%	Avoid concomitant use; if concomitant use cannot be avoided, reduce pomalidomide dosage
Ketoconazole	No substantial effect on pomalidomide exposure

Pomalidomide Pharmacokinetics

Absorption

Bioavailability

Peak plasma pomalidomide concentrations are attained about 2–3 hours after oral administration.

AUC increases in an approximately dose-proportional manner.

Food

Administration with a high-fat, high-calorie meal decreased rate of absorption by 2.5 hours, mean peak plasma concentration by 27%, and AUC by 8%.

Special Populations

Age (61–85 years), sex, and race: No substantial effect on pharmacokinetics.

Distribution

Extent

Not known whether pomalidomide is distributed into human milk.

Distributed into semen. (See Fetal/Neonatal Morbidity and Mortality under Cautions.)

Plasma Protein Binding

12–44%.

Elimination

Metabolism

Metabolized primarily by CYP1A2 and CYP3A4, with minor contributions from CYP2C19 and CYP2D6.

Elimination Route

Excreted in urine (73%) and feces (15%); minimal amounts of dose are recovered in urine and feces as unchanged drug.

Half-life

In healthy individuals, median half-life approximately 9.5 hours.

In patients with multiple myeloma or Kaposi sarcoma, median half-life approximately 7.5 hours.

Stability

Storage

Oral

Capsules

20–25°C (may be exposed to 15–30°C).

Actions

A thalidomide analog with immunomodulatory, antineoplastic, and antiangiogenic activity.
Induces direct cytotoxic and immunomodulatory effects following ubiquitination and degradation of substrate proteins (e.g., Aiolos, Ikaros).
Inhibits production of proinflammatory cytokines (e.g., tumor necrosis factor [TNF; TNF-α], interleukin-6) and increases cytolytic T-cell and natural killer (NK) cell responses.
Induces apoptosis and inhibits growth of hematopoietic tumor cells, including lenalidomide-resistant multiple myeloma cell lines.
Synergistic antitumor effects demonstrated when combined with dexamethasone in lenalidomide-sensitive and lenalidomide-resistant cell lines.
Inhibits angiogenesis in vitro and in mice bearing tumor xenografts.

Advice to Patients

Importance of educating patients regarding the Pomalyst Risk Evaluation and Mitigation Strategy (REMS) restricted distribution program for obtaining pomalidomide. (See REMS under Dosage and Administration.)
Importance of informing patients of Pregnancy Exposure Registry that monitors pregnancy outcomes in females exposed to pomalidomide during pregnancy.
Importance of advising patients to swallow capsules intact and not to break, chew, or open capsules.
Importance of advising patients that a missed dose may be taken up to 12 hours after the scheduled administration time; if more than 12 hours have elapsed, the missed dose should be omitted and the regular dosing schedule resumed the following day. Importance of not taking 2 doses at the same time to make up for a missed dose.
Risk of fetal harm. Necessity of advising women of childbearing potential to use effective methods of contraception (see Fetal/Neonatal Morbidity and Mortality under Cautions) beginning at least 4 weeks prior to initiation of therapy, throughout therapy, during dosage interruptions, and for at least 4 weeks after discontinuance of therapy; importance of obtaining pregnancy tests at appropriate intervals during therapy and of immediately discontinuing therapy and contacting their clinician if pregnancy is suspected. Necessity of advising men (including those who have successfully undergone vasectomy) to use a latex or synthetic condom during sexual encounters with women of childbearing potential; these contraceptive measures are required during and for at least 28 days after discontinuance of pomalidomide therapy. Availability of information on emergency contraception at 888-668-2528.
Importance of advising women to avoid breast-feeding while receiving pomalidomide therapy.
Importance of advising men to avoid donating semen while receiving pomalidomide and for 4 weeks after discontinuing therapy with the drug.
Importance of advising patients to avoid donating blood while receiving pomalidomide and for 1 month after discontinuing therapy with the drug.
Risk of neutropenia, thrombocytopenia, and anemia. Importance of regular monitoring of blood cell counts during pomalidomide therapy. Importance of informing clinician if signs and symptoms of neutropenia, thrombocytopenia, or anemia occur.
Risk of venous and arterial thromboembolic events; importance of advising patients to seek medical care if shortness of breath, chest pain, or swelling of the arms or legs occurs.
Risk of hepatotoxicity, including hepatic failure; importance of advising patients to report signs and symptoms of hepatotoxicity to their clinician for evaluation.
Risk of severe skin reactions; importance of advising patients to seek medical care for signs and symptoms of Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), or drug reaction with eosinophilia and systemic symptoms (DRESS).
Risk of dizziness or confusion; importance of avoiding activities where dizziness or confusion could cause serious harm to self or others. Importance of not taking other drugs that may cause dizziness or confusion without consulting their clinician.
Risk of neuropathy. Importance of informing clinician if signs and symptoms of neuropathy occur.
Possible risk of developing a second primary malignancy (i.e., acute myelogenous leukemia [AML]).
Risk of tumor lysis syndrome. Importance of informing clinician if signs and symptoms of tumor lysis syndrome occur.
Risk of severe hypersensitivity reactions; importance of advising patients to seek medical care for signs and symptoms of hypersensitivity reactions.
Advise patients that smoking may reduce the drug's efficacy.
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal supplements, as well as any concomitant illnesses.
Importance of informing patients of other important precautionary information. (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Distribution of pomalidomide is restricted. (See REMS under Dosage and Administration.)