Acetaminophen, magnesium salicylate, and pamabrom and Dabrafenib Mesylate

• Generic Name: acetaminophen / magnesium salicylate / pamabrom
• Dosage Forms: n.a.
• Other Brand Names: Pamprin Cramp Formula

Acetaminophen is a pain reliever and fever reducer.

Magnesium salicylate is a nonsteroidal anti-inflammatory drug (NSAID) in a group of drugs called salicylates (sa-LIS-il-ates). acetaminophen, magnesium salicylate, and pamabrom works by reducing substances in the body that cause pain, fever, and inflammation.

Pamabrom is a diuretic (water pill).

Acetaminophen, magnesium salicylate, and pamabrom is a combination medicine used to treat menstrual symptoms such as cramps, headache, backache, muscle aches, bloating, and fluid retention.

Acetaminophen, magnesium salicylate, and pamabrom may also be used for other purposes not listed in this medication guide.

• Generic Name: dabrafenib
• Dosage Forms: n.a.
• Other Brand Names: Tafinlar

Used in combination with trametinib as adjuvant therapy following complete resection of melanoma with BRAF V600E or V600K mutation and nodal involvement.

Used as a single agent for the treatment of unresectable or metastatic melanoma in patients with BRAF V600E mutation (designated an orphan drug by FDA as monotherapy for this use).

Used in combination with trametinib for treatment of unresectable or metastatic melanoma in patients with BRAF V600E or V600K mutation (designated an orphan drug by FDA when used in combination for this use).

FDA-approved diagnostic test (e.g., THxID BRAF kit) required to confirm presence of BRAF V600E mutation prior to initiation of monotherapy; also required to confirm presence of BRAF V600E or V600K prior to initiation of combination therapy.

Not recommended for use in patients with wild-type BRAF melanoma; safety and efficacy not established. (See Tumor Promotion in Wild-Type BRAF Tumors under Cautions.)

Used in combination with trametinib for treatment of metastatic non-small cell lung cancer (NSCLC) in patients with BRAF V600E mutation (designated an orphan drug by FDA when used in combination for this use).

FDA-approved diagnostic test (e.g., THxID BRAF kit) required to confirm presence of BRAF V600E mutation prior to initiation of therapy.

Not recommended for use in patients with wild-type BRAF NSCLC; safety and efficacy not established. (See Tumor Promotion in Wild-Type BRAF Tumors under Cautions.)

Used in combination with trametinib for treatment of locally advanced or metastatic anaplastic thyroid cancer in patients with BRAF V600E mutation when no satisfactory locoregional treatment options are available (designated an orphan drug by FDA when used in combination for this use).

FDA-approved diagnostic test (e.g., THxID BRAF kit) required to confirm presence of BRAF V600E mutation prior to initiation of therapy.

Not recommended for use in patients with wild-type BRAF anaplastic thyroid cancer; safety and efficacy not established. (See Tumor Promotion in Wild-Type BRAF Tumors under Cautions.)