Alectinib Hydrochloride and DuraTan DM

• Generic Name: alectinib
• Dosage Forms: n.a.
• Other Brand Names: Alecensa

Treatment of ALK-positive metastatic NSCLC in patients following failure (secondary to resistance or intolerance) of prior crizotinib therapy (designated an orphan drug by FDA for this use).

Accelerated approval based on tumor response rate and duration of response; continued approval may be contingent on verification and description of clinical benefit in confirmatory studies.

About 3–7% of patients with NSCLC have ALK-positive disease; such patients typically are nonsmokers or light smokers, female, and younger in age, and often have adenocarcinoma.

Long-term therapeutic potential of crizotinib (another ALK inhibitor) is limited by eventual development of secondary resistance and development and/or progression of brain metastases (because of poor distribution of crizotinib into CSF). (See Actions.) Responses to alectinib in patients with crizotinib-refractory ALK-positive metastatic NSCLC have included objective CNS responses.

• Generic Name: brompheniramine / dextromethorphan / phenylephrine
• Dosage Forms: n.a.
• Other Brand Names: Alahist DM, BP Allergy DM, Bromatan-DM, Children's Cold & Cough DM, Cold & Cough Childrens, Dimaphen DM, Dimetapp Cold & Cough, Dimetapp DM Cold & Cough, DuraTan DM, Rynex DM, TL-Hist DM, Tussi-Pres B, Dimetapp DM Cold/Cough, Glenmax PEB DM FORTE, Glenmax PEB DM, LoHist-DM, Niva-Hist DM, TGQ 75PEH/4BRM/15DM

Brompheniramine is an antihistamine that reduces the effects of the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Dextromethorphan is a cough suppressant. It affects the signals in the brain that trigger cough reflex.

Phenylephrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

The combination of brompheniramine, dextromethorphan, and phenylephrine is used to treat runny or stuffy nose, sneezing, itching, watery eyes, cough, and sinus congestion caused by allergies, the common cold, or the flu.

DuraTan DM will not treat a cough that is caused by smoking, asthma, or emphysema.

DuraTan DM may also be used for purposes not listed in this medication guide.