Cotellic

Instructions for Cotellic

Common name: Cotellic

Trade name: Cotellic

All names: Cotellic, Cotellic, Cotellic, Cobimetinib

Cobimetinib indications:

Carrying BRAF Advanced melanoma that has a V600E or V600K gene mutation, has spread to other parts of the body, or cannot be removed by surgery.

Cobimetinib dosage and administration

⑴ Confirm the presence of BRAF V600E or V600K mutation in tumor specimens before starting treatment with COTELLIC.

⑵ The recommended dose is 60 mg orally once daily for the first 21 days of each 28-day course until disease progression or unacceptable toxicity. Take COTELLIC with or without food.

Cotellic dosage forms and specifications:

Tablets, 20 mg each

Cotellic mechanism of action:

Cotellic prevents or slows down the growth of cancer cells by inhibiting the activity of MEK.

Common adverse reactions to Cotellic:

Including damage to the heart muscle (cardiomyopathy) or other muscle damage (rhabdomyolysis), new skin tumors (primary cutaneous malignancies), eye disease (retinal detachment), severe rash, liver damage (hepatotoxicity), bleeding, and severe rash caused by increased light sensitivity.

Cotellic Warnings and Precautions:

(1) New primary malignancy, cutaneous and non-cutaneous: Monitor patients for new malignancies before initiation of treatment, while on treatment, and until 6 months after the last dose of COTELLIC.

⑵ Bleeding: Monitor for signs and symptoms of bleeding that may occur with COTELLIC.

⑶ Cardiomyopathy: The risk of cardiomyopathy is increased in patients receiving COTELLIC compared with vemurafenib as a single agent. .The safety of COTELLIC has not been established in patients with reduced left ventricular ejection component (LVEF). LVEF was assessed during treatment with COTELLIC before treatment, 1 month after treatment, and then every 3 months thereafter.

⑷ Severe dermatological reactions: Monitor for severe rash. Interrupt, reduce, or terminate COTELLIC.

⑸ Severe retinopathy and retinal vein occlusion: Perform ophthalmological examination at regular intervals and for any visual impairment. Permanently discontinue COTELLIC for retinal vein occlusion (RVO).

⑹ Hepatotoxicity: Monitor liver laboratory tests during treatment and when clinically indicated.

⑺ Rhabdomyolysis Syndrome: Monitor creatine phosphokinase regularly and when clinically indicated for signs and symptoms of rhabdomyolysis syndrome.

⑻ Severe light sensitivity: Advise patients to avoid sun exposure.

⑼ Embryo-fetal toxicity: May cause fetal harm. Advise females of reproductive potential of the potential risks to the fetus and to use effective contraception.

Cotellic Adverse Reactions:

The most common adverse reactions (≥20%) to COTELLIC are diarrhea, photosensitivity, nausea, pyrexia, and vomiting.

The most common (≥5%) grade 3-4 laboratory abnormalities are increased GGT, increased CPK, hypophosphatemia, increased ALT, lymphopenia, increased AST, increased alkaline phosphatase, and hyponatremia.