Cetylev oral, effervescent and Trametinib Dimethyl Sulfoxide

• Generic Name: acetylcysteine
• Dosage Forms: tablet, effervescent
• Other Brand Names: Cetylev, Mucomyst-10

Cetylev is an acetaminophen antidote that helps your body preserve a substance that can help detoxify the liver.

Cetylev is used to treat acetaminophen overdose and help prevent damage to your liver caused by taking large quantities of acetaminophen (Tylenol).

There are other brands and forms of acetylcysteine available, and some can be purchased over the counter. Not all forms of Cetylev are effective as an acetaminophen antidote. Treatment of acetaminophen overdose should be managed by a medical doctor.

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

• Generic Name: trametinib
• Dosage Forms: n.a.
• Other Brand Names: Mekinist

In combination with dabrafenib as adjuvant therapy following complete resection of melanoma with BRAF V600E or V600K mutation and nodal involvement.

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

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

Not recommended for use in patients with melanoma who have experienced disease progression following treatment with a BRAF inhibitor.

Used in combination with dabrafenib 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.

Used in combination with dabrafenib 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.