"The U.S. Food and Drug Administration today granted accelerated approval to Zykadia (ceritinib) for patients with a certain type of late-stage (metastatic) non-small cell lung cancer (NSCLC).
Zykadia is an anaplastic lymphoma kinase (ALK)"...
Advise patients to contact their health care provider for:
- Severe or persistent diarrhea, nausea, anorexia, or vomiting [see ADVERSE REACTIONS]
- Onset or worsening of unexplained shortness of breath or cough [see WARNINGS AND PRECAUTIONS]
- Eye irritation [see WARNINGS AND PRECAUTIONS]
- Onset or worsening of skin rash or development of bullous lesions or desquamation [see WARNINGS AND PRECAUTIONS]
- Any changes in smoking status [see CLINICAL PHARMACOLOGY]
Advise patients on the presentation of skin, hair and nail disorders.
- In patients who develop skin rash, the appearance of the rash is typically erythematous and maculopapular and it may resemble acne with follicular pustules, but is histopathologically different. This skin reaction commonly occurs on the face, upper chest and back, but may be more generalized or severe (NCI-CTC Grade 3 or 4) with desquamation. Skin reactions may occur or worsen in sun exposed areas. Symptoms associated with rash may include itching, tenderness and/or burning.
- Hyperpigmentation or dry skin, with or without digital skin fissures, have been reported and in the majority of cases were associated with rash.
- Hair and nail disorders, including hirsutism and brittle and loose nails, have been reported.
Instruct patients on initial management of rash or diarrhea.
- Given that skin reactions are anticipated when taking TARCEVA, proactive intervention may include alcohol-free emollient cream and use of sunscreen or avoidance of sun exposure [see ADVERSE REACTIONS].
- Management of rash may include topical corticosteroids or antibiotics with anti-inflammatory properties. These approaches were used in the NSCLC and pancreatic pivotal clinical trials. Acne preparations with drying properties may aggravate the dry skin and erythema. Treatment of rash has not been formally studied and should be based on rash severity.
- Diarrhea can usually be managed with loperamide.
Counsel patients on pregnancy planning and prevention.
- Advise females of reproductive potential to use highly effective contraception during treatment with TARCEVA, and for at least 2 weeks after the last dose of TARCEVA.
- Advise patients to contact their healthcare provider if they become pregnant, or if pregnancy is suspected, during treatment with TARCEVA [see Use In Specific Populations].
- Advise breast-feeding mothers to discontinue nursing while receiving TARCEVA [see Use in Specific Populations].
Advise patients to stop smoking. Advise patients that the dose of TARCEVA may need to be adjusted if they smoke. [see CLINICAL PHARMACOLOGY].
Last reviewed on RxList: 4/28/2014
This monograph has been modified to include the generic and brand name in many instances.
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