Cotellic

— THERAPEUTIC CATEGORIES —
  • Leukemias, lymphomas, and other hematologic cancers
  • Melanoma and other skin cancers

Cotellic Generic Name & Formulations

General Description

Cobimetinib 20mg; tabs.

Pharmacological Class

Kinase inhibitor.

How Supplied

Tabs—63

Manufacturer

Generic Availability

NO

Cotellic Indications

Indications

As a single agent for the treatment of adults with histiocytic neoplasms.

Cotellic Dosage and Administration

Adult

Give 60mg once daily for first 21 days of each 28-day cycle until disease progression or unacceptable toxicity. Concomitant CYP3A inhibitors: see Interactions. Other dose modifications: see full labeling.

Children

Not established.

Cotellic Contraindications

Not Applicable

Cotellic Boxed Warnings

Not Applicable

Cotellic Warnings/Precautions

Warnings/Precautions

Review full labeling for vemurafenib prior to initiation. Monitor for new malignancies (cutaneous and non-cutaneous); perform skin evaluations prior to initiation, every 2 months during therapy, and for 6 months after discontinuation. Monitor for signs/symptoms of bleeding; withhold if Grade 3 hemorrhagic events occur; resume at lower dose if improved to Grade 0/1 within 4 weeks; discontinue if no improvement. Risk of cardiomyopathy; assess LVEF prior to initiation, after 1 month, and then every 3 months thereafter until discontinuation. Patients with baseline LVEF below institutional lower limit of normal or <50%: not established. Interrupt, reduce dose, or discontinue if severe skin reactions occur. Perform eye exams at regular intervals and for any visual disturbances. Manage serous retinopathy with treatment interruption, dose reduction, or discontinuation. Permanently discontinue if retinal vein occlusion occurs. Monitor liver tests prior to initiation, monthly during treatment, or more frequently as indicated; dose interruption, reduction, or discontinuation if Grade 3/4 abnormalities occur. Obtain baseline CPK and creatinine levels prior to initiation, periodically during treatment, and as clinically indicated for signs/symptoms of rhabdomyolysis. Avoid sun exposure. Severe renal impairment. Embryo-fetal toxicity. Females of reproductive potential should use effective contraception during therapy and for 2 weeks after final dose. Pregnancy. Nursing mothers: not recommended (during therapy and for 2 weeks after final dose).

Cotellic Pharmacokinetics

See Literature

Cotellic Interactions

Interactions

Avoid concomitant strong or moderate CYP3A inhibitors (eg, itraconazole, erythromycin, ciprofloxacin). If short-term (≤14 days) use of moderate CYP3A inhibitors is unavoidable for patients taking cobimetinib 60mg, reduce to 20mg and resume at previous dose upon discontinuing the CYP3A inhibitor; for patients taking cobimetinib 20mg or 40mg, use alternative. Avoid concomitant strong or moderate CYP3A inducers (eg, carbamazepine, efavirenz, phenytoin, rifampin, St. John's wort).

Cotellic Adverse Reactions

Adverse Reactions

Acneiform dermatitis, diarrhea, infection, fatigue, nausea, edema, dry skin, maculopapular rash, pruritus, dyspepsia, vomiting, dyspnea, UTIs, grade 3/4 lab abnormalities (hyponatremia, increased blood creatine phosphokinase, hypokalemia, increased blood creatinine, increased AST, hypocalcemia, lymphopenia, leukopenia, anemia).

Cotellic Clinical Trials

See Literature

Cotellic Note

Not Applicable

Cotellic Patient Counseling

See Literature

Cotellic Generic Name & Formulations

General Description

Cobimetinib 20mg; tabs.

Pharmacological Class

Kinase inhibitor.

How Supplied

Tabs—63

Manufacturer

Generic Availability

NO

Cotellic Indications

Indications

In combination with vemurafenib for the treatment of unresectable or metastatic melanoma with BRAF V600E or V600K mutations.

Cotellic Dosage and Administration

Adult

Confirm presence of BRAF V600E or V600K mutation prior to initiation. In combination with vemurafenib: 60mg once daily for first 21 days of each 28-day cycle until disease progression or unacceptable toxicity. Concomitant CYP3A inhibitors: see Interactions. Other dose modifications: see full labeling.

Children

Not established.

Cotellic Contraindications

Not Applicable

Cotellic Boxed Warnings

Not Applicable

Cotellic Warnings/Precautions

Warnings/Precautions

Review full labeling for vemurafenib prior to initiation. Monitor for new malignancies (cutaneous and non-cutaneous); perform skin evaluations prior to initiation, every 2 months during therapy, and for 6 months after discontinuation. Monitor for signs/symptoms of bleeding; withhold if Grade 3 hemorrhagic events occur; resume at lower dose if improved to Grade 0/1 within 4 weeks; discontinue if no improvement. Risk of cardiomyopathy; assess LVEF prior to initiation, after 1 month, and then every 3 months thereafter until discontinuation. Patients with baseline LVEF below institutional lower limit of normal or <50%: not established. Interrupt, reduce dose, or discontinue if severe skin reactions occur. Perform eye exams at regular intervals and for any visual disturbances. Manage serous retinopathy with treatment interruption, dose reduction, or discontinuation. Permanently discontinue if retinal vein occlusion occurs. Monitor liver tests prior to initiation, monthly during treatment, or more frequently as indicated; dose interruption, reduction, or discontinuation if Grade 3/4 abnormalities occur. Obtain baseline CPK and creatinine levels prior to initiation, periodically during treatment, and as clinically indicated for signs/symptoms of rhabdomyolysis. Avoid sun exposure. Severe renal impairment. Embryo-fetal toxicity. Females of reproductive potential should use effective contraception during therapy and for 2 weeks after final dose. Pregnancy. Nursing mothers: not recommended (during therapy and for 2 weeks after final dose).

Cotellic Pharmacokinetics

See Literature

Cotellic Interactions

Interactions

Avoid concomitant strong or moderate CYP3A inhibitors (eg, itraconazole, erythromycin, ciprofloxacin). If short-term (≤14 days) use of moderate CYP3A inhibitors is unavoidable for patients taking cobimetinib 60mg, reduce to 20mg and resume at previous dose upon discontinuing the CYP3A inhibitor; for patients taking cobimetinib 20mg or 40mg, use alternative. Avoid concomitant strong or moderate CYP3A inducers (eg, carbamazepine, efavirenz, phenytoin, rifampin, St. John's wort).

Cotellic Adverse Reactions

Adverse Reactions

Diarrhea, photosensitivity, nausea, pyrexia, vomiting, grade 3/4 lab abnormalities (increased GGT, CPK, ALT/AST and alkaline phosphatase, hypophosphatemia, lymphopenia, hyponatremia).

Cotellic Clinical Trials

See Literature

Cotellic Note

Not Applicable

Cotellic Patient Counseling

See Literature

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