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Encorafenib

Medically reviewed by Drugs.com. Last updated on Jun 23, 2019.

Pronunciation

(en koe RAF e nib)

Index Terms

  • LGX 818

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Capsule, Oral:

Braftovi: 50 mg [DSC], 75 mg

Brand Names: U.S.

  • Braftovi

Pharmacologic Category

  • Antineoplastic Agent, BRAF Kinase Inhibitor

Pharmacology

Encorafenib is an ATP-competitive inhibitor of protein kinase B-raf (BRAF) which suppresses the MAPK pathway (Dummer 2018). Encorafenib targets BRAF V600E, V600 D, and V600 K, and has a longer dissociation half-life than other BRAF inhibitors, allowing for sustained inhibition (Dummer 2018). BRAF V600 mutations result in constitutive activation of the BRAF pathway (which may stimulate tumor growth); BRAF inhibition inhibits tumor cell growth. The combination of encorafenib and binimetinib allows for greater antitumor activity in BRAF V600 mutant cell lines; in animal studies, the combination also delayed the emergence of resistance in BRAF V600E mutant cells compared to either drug alone.

Absorption

At least 86% of the dose is absorbed

Distribution

164 L

Metabolism

N-dealkylation is the primary metabolic pathway; CYP3A4 (primary), CYP2C19, and CYP2D6 (minor) contribute to total oxidative clearance in human liver microsomes

Excretion

Feces (47%; 5% as unchanged drug); urine (47%; 2% as unchanged drug)

Time to Peak

2 hours

Half-Life Elimination

3.5 hours

Protein Binding

86% to plasma proteins

Use: Labeled Indications

Melanoma, unresectable or metastatic: Treatment of unresectable or metastatic melanoma with a BRAF V600E or V600K mutation (in combination with binimetinib) as detected by an approved test.

Limitations of use: Encorafenib is not indicated for treatment of wild-type BRAF melanoma.

Off Label Uses

Colorectal cancer, metastatic, refractory (RAS wild-type, BRAF V600E-mutant)

Data from the multicenter safety lead-in portion of a phase III study suggest that encorafenib (in combination with binimetinib and cetuximab) may be efficacious in the treatment of metastatic RAS wild-type colorectal cancer in patients with BRAF V600E-mutant tumors and disease progression following 1 to 2 prior therapies [Van Cutsem 2019].

Contraindications

There are no contraindications listed in the manufacturer's labeling.

Dosing: Adult

Note: Confirm BRAF V600 mutation status prior to treatment initiation.

Colorectal cancer, metastatic, refractory, RAS wild-type, BRAF V600E-mutant (off-label use): Oral: 300 mg once daily (in combination with binimetinib and cetuximab) until disease progression or unacceptable toxicity (Van Cutsem 2019). Refer to protocol for dosage modification recommendations.

Melanoma, unresectable or metastatic (with BRAF V600E or BRAF V600K mutation): Oral: 450 mg once daily (in combination with binimetinib) until disease progression or unacceptable toxicity (Dummer 2018).

Dosage adjustment for concomitant moderate or strong CYP3A4 inhibitors: Avoid the use of concomitant moderate or strong CYP3A4 inhibitors; if concomitant use cannot be avoided, reduce the encorafenib dose when administered with a strong CYP3A4 inhibitor (if existing dose was 450 mg, reduce dose to 150 mg; if existing dose was 300 mg or 225 mg, reduce dose to 75 mg) or a moderate CYP3A4 inhibitor (if existing dose was 450 mg, reduce dose to 225 mg; if existing dose was 300 mg, reduce dose to 150 mg; if existing dose was 225 mg, reduce dose to 75 mg). After the inhibitor has been discontinued for 3 to 5 elimination half-lives, resume the encorafenib dose that was used prior to initiating the CYP3A4 inhibitor.

Missed doses: Do not administer a missed dose if <12 hours until the next dose. Do not take an additional dose if vomiting occurs after encorafenib administration; resume with the next scheduled dose.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Adjustment for Toxicity

Note: If encorafenib is permanently discontinued, discontinue binimetinib. If binimetinib is withheld, reduce encorafenib dose to a maximum of 300 mg once daily until binimetinib therapy is resumed. Refer to the Binimetinib monograph for recommended binimetinib dose reductions.

When used in combination with binimetinib, encorafenib dosage modification is not recommended for new primary cutaneous malignancies, ocular events (other than uveitis, iritis, and iridocyclitis), interstitial lung disease/pneumonitis, cardiac dysfunction (other than QTc prolongation), creatine phosphokinase elevation, rhabdomyolysis, and venous thromboembolism.

Recommended encorafenib dose reductions for toxicity:

First dose reduction: 300 mg once daily

Second dose reduction: 225 mg once daily

Subsequent modifications (if unable to tolerate 225 mg once daily): Permanently discontinue encorafenib.

Dermatologic toxicity:

Grade 2 toxicity: If no improvement within 2 weeks, withhold encorafenib until ≤ grade 1, then resume at the same dose.

Grade 3 toxicity: Withhold encorafenib until ≤ grade 1; resume at the same dose if first occurrence, or reduce the dose if recurrent grade 3 toxicity.

Grade 4 toxicity: Permanently discontinue encorafenib.

Ocular toxicity:

Uveitis including iritis and iridocyclitis: If grade 1 or 2 uveitis does not respond to specific ocular therapy (or for grade 3 uveitis), interrupt encorafenib therapy for up to 6 weeks. If improves within 6 weeks following therapy interruption, resume at the same dose or a lower dose. If does not improve, permanently discontinue encorafenib. Permanently discontinue for grade 4 uveitis.

QTc prolongation:

QTcF >500 msec and ≤60 msec increase from baseline: Withhold encorafenib until QTcF is ≤500 msec; then resume at a reduced dose. If more than 1 recurrence, permanently discontinue encorafenib.

QTcF >500 msec and >60 msec increase from baseline: Permanently discontinue encorafenib.

Other toxicity (including hemorrhage):

Recurrent grade 2 or first occurrence of any grade 3 toxicity: Interrupt encorafenib therapy for up to 4 weeks; if improves to ≤ grade 1 or to pretreatment/baseline level, resume at a reduced dose. If no improvement, permanently discontinue encorafenib.

Grade 3 toxicity (recurrent): Consider permanently discontinuing encorafenib.

Grade 4 toxicity (first occurrence): Permanently discontinue encorafenib or withhold encorafenib therapy for up to 4 weeks until improvement to ≤ grade 1 or to pretreatment/baseline level, then resume at a reduced dose (permanently discontinue if no improvement).

Grade 4 toxicity (recurrent): Permanently discontinue encorafenib.

New primary noncutaneous malignancy (RAS mutation-positive): Permanently discontinue encorafenib.

Administration

Oral: Administer once daily with or without food.

Storage

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Dispense in original bottle; do not remove desiccant. Protect from moisture.

Drug Interactions

Clofazimine: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

Conivaptan: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Avoid combination

CYP3A4 Inducers (Moderate): May decrease the serum concentration of Encorafenib. Avoid combination

CYP3A4 Inducers (Strong): May decrease the serum concentration of Encorafenib. Avoid combination

CYP3A4 Inhibitors (Moderate): May increase the serum concentration of Encorafenib. Management: Avoid concomitant use of encorafenib and moderate CYP3A4 inhibitors whenever possible. If concomitant administration is unavoidable, decrease the encorafenib dose prior to initiation of the CYP3A4 inhibitor. See full monograph for details. Consider therapy modification

CYP3A4 Inhibitors (Strong): May increase the serum concentration of Encorafenib. Management: Avoid concomitant use of encorafenib and strong CYP3A4 inhibitors whenever possible. If concomitant administration is unavoidable, decrease the encorafenib dose. See monograph for details. Consider therapy modification

Deferasirox: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy

Domperidone: QT-prolonging Agents (Moderate Risk) may enhance the QTc-prolonging effect of Domperidone. Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Consider therapy modification

Dronedarone: Encorafenib may enhance the QTc-prolonging effect of Dronedarone. Dronedarone may increase the serum concentration of Encorafenib. Management: Avoid using dronedarone with encorafenib if possible. If the combination must be used, reduce the encorafenib dose prior to initiation of dronedarone and monitor QT interval. See full monograph for details. Consider therapy modification

Erdafitinib: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy

Erdafitinib: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

Estrogen Derivatives (Contraceptive): Encorafenib may decrease the serum concentration of Estrogen Derivatives (Contraceptive). Avoid combination

Fosaprepitant: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

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

Haloperidol: QT-prolonging Kinase Inhibitors (Moderate Risk) may enhance the QTc-prolonging effect of Haloperidol. Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Monitor therapy

Idelalisib: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Avoid combination

Larotrectinib: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

Lefamulin: May enhance the QTc-prolonging effect of QT-prolonging CYP3A4 Substrates. Management: Do not use lefamulin tablets with QT-prolonging CYP3A4 substrates. Lefamulin prescribing information lists this combination as contraindicated. Avoid combination

MiFEPRIStone: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Management: Minimize doses of CYP3A4 substrates, and monitor for increased concentrations/toxicity, during and 2 weeks following treatment with mifepristone. Avoid cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, and tacrolimus. Consider therapy modification

Ondansetron: May enhance the QTc-prolonging effect of QT-prolonging Kinase Inhibitors (Moderate Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Monitor therapy

Palbociclib: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

Pentamidine (Systemic): May enhance the QTc-prolonging effect of QT-prolonging Kinase Inhibitors (Moderate Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Monitor therapy

Pimozide: May enhance the QTc-prolonging effect of QT-prolonging Agents (Moderate Risk). Avoid combination

Posaconazole: May increase the serum concentration of QT-prolonging CYP3A4 Substrates. Such increases may lead to a greater risk for proarrhythmic effects and other similar toxicities. Avoid combination

Progestins (Contraceptive): Encorafenib may decrease the serum concentration of Progestins (Contraceptive). Avoid combination

QT-prolonging Agents (Highest Risk): Encorafenib may enhance the QTc-prolonging effect of QT-prolonging Agents (Highest Risk). Management: Consider alternatives to this combination. Patients with other risk factors (eg, older age, female sex, bradycardia, hypokalemia, hypomagnesemia, heart disease, and higher drug concentrations) are likely at greater risk for these toxicities. Exceptions: Dronedarone. Consider therapy modification

QT-prolonging Antidepressants (Moderate Risk): May enhance the QTc-prolonging effect of QT-prolonging Kinase Inhibitors (Moderate Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Monitor therapy

QT-prolonging Antipsychotics (Moderate Risk): May enhance the QTc-prolonging effect of QT-prolonging Kinase Inhibitors (Moderate Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Exceptions: Pimozide. Monitor therapy

QT-prolonging Class IC Antiarrhythmics (Moderate Risk): May enhance the QTc-prolonging effect of QT-prolonging Kinase Inhibitors (Moderate Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Monitor therapy

QT-prolonging Kinase Inhibitors (Moderate Risk): May enhance the QTc-prolonging effect of other QT-prolonging Kinase Inhibitors (Moderate Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Monitor therapy

QT-prolonging Miscellaneous Agents (Moderate Risk): QT-prolonging Kinase Inhibitors (Moderate Risk) may enhance the QTc-prolonging effect of QT-prolonging Miscellaneous Agents (Moderate Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Exceptions: Domperidone. Monitor therapy

QT-prolonging Moderate CYP3A4 Inhibitors (Moderate Risk): Encorafenib may enhance the QTc-prolonging effect of QT-prolonging Moderate CYP3A4 Inhibitors (Moderate Risk). QT-prolonging Moderate CYP3A4 Inhibitors (Moderate Risk) may increase the serum concentration of Encorafenib. Management: Avoid using moderate CYP3A4 inhibitors together with encorafenib if possible. If the combination must be used, reduce the encorafenib dose prior to initiation of the moderate CYP3A4 inhibitor and monitor QT interval. See full monograph for details. Consider therapy modification

QT-prolonging Quinolone Antibiotics (Moderate Risk): May enhance the QTc-prolonging effect of QT-prolonging Kinase Inhibitors (Moderate Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Monitor therapy

QT-prolonging Strong CYP3A4 Inhibitors (Moderate Risk): Encorafenib may enhance the QTc-prolonging effect of QT-prolonging Strong CYP3A4 Inhibitors (Moderate Risk). QT-prolonging Strong CYP3A4 Inhibitors (Moderate Risk) may increase the serum concentration of Encorafenib. Management: Avoid using strong CYP3A4 inhibitors together with encorafenib if possible. If the combination must be used, reduce the encorafenib dose and monitor QT interval. See monograph for details. Consider therapy modification

Sarilumab: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy

Siltuximab: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy

Simeprevir: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

Stiripentol: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). 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

Tocilizumab: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy

Adverse Reactions

Incidences of adverse reactions include those defined during combination therapy with binimetinib. Encorafenib when used as a single agent is associated with an increased risk of certain adverse reactions.

>10%:

Central nervous system: Fatigue (43%), headache (22%), dizziness (15%), peripheral neuropathy (12%)

Dermatologic: Hyperkeratosis (23% to 57%), alopecia (14% to 56%), palmar-plantar erythrodysesthesia (7% to 51%), skin rash (22% to 41%), xeroderma (16% to 38%), pruritus (13% to 31%), dermatological reaction (2% to 21%), erythema (7% to 16%)

Endocrine & metabolic: Increased gamma-glutamyl transferase (45%), hyperglycemia (28%), hyponatremia (18%)

Gastrointestinal: Nausea (41%), vomiting (30%), abdominal pain (28%), constipation (22%), dysgeusia (6% to 13%)

Hematologic & oncologic: Anemia (36%; grades 3/4: 4%), hemorrhage (19%; grades 3/4: 3%), leukopenia (13%), lymphocytopenia (13%; grades 3/4: 2%), neutropenia (13%; grades 3/4: 3%)

Hepatic: Increased serum alanine aminotransferase (29%), increased serum aspartate aminotransferase (27%), increased serum alkaline phosphatase (21%)

Neuromuscular & skeletal: Arthralgia (26% to 44%), myopathy (23% to 33%), back pain (9% to 15%), limb pain (11%)

Renal: Increased serum creatinine (93%)

Miscellaneous: Fever (18%)

1% to 10%:

Central nervous system: Facial paresis (<10%)

Dermatologic: Acneiform eruption (3% to 8%)

Endocrine & metabolic: Hypermagnesemia (10%)

Gastrointestinal: Pancreatitis (<10%), hematochezia (3%), hemorrhoidal bleeding (1%)

Hypersensitivity: Hypersensitivity (<10%)

Hematologic & oncologic: Squamous cell carcinoma of skin (3% to 8%), malignant melanoma (5%), rectal hemorrhage (4%), keratoacanthoma (3%), basal cell carcinoma (1% to 2%)

Neuromuscular & skeletal: Panniculitis (<10%)

Ophthalmic: Uveitis (4%)

<1%, postmarketing, and/or case reports: Prolonged QT interval on ECG

Warnings/Precautions

Concerns related to adverse effects:

• Dermatologic toxicity: Grade 3 or 4 dermatologic toxicity occurred in ~20% of patients receiving encorafenib as a single agent, compared to 2% of patients receiving the combination of encorafenib and binimetinib.

• Hemorrhage: Hemorrhage, including ≥ grade 3 events, may occur when administered in combination with binimetinib. The most frequent hemorrhagic events were GI in nature, including rectal hemorrhage, hematochezia, and hemorrhoidal hemorrhage. Fatal intracranial hemorrhage (in the setting of new or progressive brain metastases) was also reported. May require treatment interruption, dosage reduction, or permanent discontinuation based on the severity of the hemorrhage.

• Malignancy: New primary malignancies (cutaneous and noncutaneous) have been observed in patients treated with BRAF inhibitors and may occur with encorafenib. Cutaneous squamous cell carcinoma (cuSCC), including keratoacanthoma (KA), as well as basal cell carcinoma occurred in patients receiving encorafenib in combination with binimetinib; the median time to first onset of cuSCC/KA was ~6 months (range: 1 to 9 months). Cases of cuSCC/KA, basal cell carcinoma, and new primary melanoma were also observed in patients receiving encorafenib monotherapy. Dermatologic evaluations should be performed prior to initiating therapy, every 2 months during therapy, and for up to 6 months post discontinuation. Suspicious skin lesions may be managed with excision and dermatopathologic evaluation; dose modification is not recommended for new primary cutaneous malignancies. Due to its mechanism of action (activation of RAS through mutation or other mechanisms), other noncutaneous malignancies may develop with encorafenib use; monitor for signs/symptoms of noncutaneous malignancies. Discontinue encorafenib for RAS mutation-positive noncutaneous malignancies.

• Ocular toxicity: Uveitis, including iritis and iridocyclitis, has been observed with the combination of encorafenib and binimetinib. Monitor for ocular toxicity at each visit; perform an ophthalmologic evaluation regularly and for new or worsening visual disturbances (and to follow new or persistent ophthalmologic findings). May require treatment interruption, dosage reduction, or permanent discontinuation based on the severity of the toxicity.

• QT prolongation: Encorafenib is associated with dose dependent QTc interval prolongation. In a clinical trial, QTcF prolongation to >500 msec was reported (rare) when used in combination with binimetinib. Monitor patients with or at risk for developing QTc prolongation, including those with known long QT syndromes, clinically significant bradyarrhythmias, severe or uncontrolled heart failure, or concomitant use of medications associated with QT prolongation. Correct hypokalemia or hypomagnesemia prior to treatment initiation. QT prolongation may require treatment interruption, dosage reduction, or permanent discontinuation based on the severity of the toxicity.

Concurrent drug therapy issues:

• Combination therapy with binimetinib: Additional toxicities may occur when used in combination with binimetinib (MEK inhibitor). Refer to the Binimetinib monograph for further information on warnings/precautions or binimetinib dosage modifications. If binimetinib therapy is withheld or permanently discontinued, the encorafenib dose should also be reduced (see Dosing: Adjustment for Toxicity).

• 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.

Other warnings/precautions:

• Appropriate use: Encorafenib is not indicated for treatment of patients with wild-type BRAF melanoma. Exposing BRAF wild-type cells to BRAF inhibitors such as encorafenib may result in paradoxical activation of MAP-kinase signaling and increased cell proliferation. Prior to initiating therapy, confirm BRAF V600E or BRAF V600K mutation status with an approved test. Information on approved tests for detection of BRAF V600 mutations is available at http://www.fda.gov/companiondiagnostics.

Monitoring Parameters

BRAFV600K or V600E mutation status (prior to treatment); electrolytes; verify pregnancy status in females of reproductive potential prior to treatment initiation; dermatologic evaluations prior to initiation, every 2 months during therapy, and for up to 6 months following discontinuation to assess for new cutaneous malignancies; monitor for signs/symptoms of uveitis (eg, eye pain, photophobia, vision changes), hemorrhage, and dermatologic toxicity, and for noncutaneous malignancies. Monitor adherence.

Pregnancy Considerations

Based on its mechanism of action and on findings in animal reproduction studies, encorafenib may cause fetal harm if administered during pregnancy.

Verify pregnancy status in females of reproductive potential prior to initiating encorafenib therapy. Females of reproductive potential should use a highly effective nonhormonal contraceptive during therapy and for at least 2 weeks after the last encorafenib dose; hormonal contraceptives may not be effective.

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 dizziness, fatigue, nausea, vomiting, abdominal pain, muscle pain, joint pain, back pain, constipation, painful extremities, hard or thick skin, dry skin, acne, hair loss, or change in taste. Have patient report immediately to prescriber signs of bleeding (vomiting blood or vomit that looks like coffee grounds; coughing up blood; hematuria; black, red, or tarry stools; bleeding from the gums; abnormal vaginal bleeding; bruises without a reason or that get bigger; or any severe or persistent bleeding), signs of electrolyte problems (mood changes, confusion, muscle pain or weakness, abnormal heartbeat, seizures, lack of appetite, or severe nausea or vomiting), signs of high blood sugar (confusion, fatigue, increased thirst, increased hunger, polyuria, flushing, fast breathing, or breath that smells like fruit), signs of severe cerebrovascular disease (change in strength on one side is greater than the other, difficulty speaking or thinking, change in balance, or vision changes), chills, vision changes, eye pain, severe eye irritation, seeing colored dots, seeing halos or bright colors around lights, severe headache, mole changes, skin changes, impaired skin wound healing, burning or numbness feeling, redness or irritation of palms of hands or soles of feet, severe loss of strength and energy, tachycardia, abnormal heartbeat, or passing out (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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