New PMI Monographs

Fosaprepitant Injection (Emend^®)

Fosaprepitant injection is used along with other medications to prevent nausea and vomiting in adults that may occur within 24 hours after receiving cancer chemotherapy treatment. It is also used along with other medications to prevent delayed nausea and vomiting that may occur several days after receiving certain chemotherapy medications.

Enasidenib (Idhifa^®)

Enasidenib is used to treat a certain type of acute myeloid leukemia (AML; a type of cancer that begins in the white blood cells) that has worsened or come back after treatment with other chemotherapy medications.

Inotuzumab Ozogamicin Injection (Besponsa^®)

Inotuzumab ozogamicin injection is used to treat certain acute lymphoblastic leukemia (ALL; a type of cancer that begins in the white blood cells) in adults who have not responded to previous cancer treatments.

Glecaprevir and Pibrentasvir (Mavyret^®)

The combination of glecaprevir and pibrentasvir is used to treat certain types of chronic (long-term) hepatitis C infection (swelling of the liver caused by a virus).

FDA MedWatch Alert Revisions

Obeticholic Acid (Ocaliva^®)

FDA is warning that the liver disease medicine obeticholic acid is being incorrectly dosed in some patients with moderate to severe decreases in liver function, resulting in an increased risk of serious liver injury and death.

Methadone (Dolophine^®) & Buprenorphine (Subutex^®)

FDA is advising that the opioid addiction medications buprenorphine and methadone should not be withheld from patients taking benzodiazepines or other drugs that depress the central nervous system (CNS).

The October update to the AHFS Drug Information/Essentials database has been published. Highlights from this month’s update include:

New First-Release Monographs

Gemtuzumab Ozogamicin (Mylotarg^®) – 10:00 (Antineoplastic Agents)
- Gemtuzumab was removed from US market June 2010 and reapproved September 2017 with many changes
- New indications:
  - Treatment of newly diagnosed CD33-positive acute myeloid leukemia in adults.
  - Treatment of relapsed or refractory CD33-positive AML in adults and in pediatric patients 2 years and older.
Deutetrabenazine (Austedo^®) – 28:92 (Central Nervous System Agents, Miscellaneous)
- Treatment of chorea associated with Huntington’s disease.
- Treatment of tardive dyskinesia in adults.
Daunorubicin And Cytarabine (Vyxeos^®) – 10:00 (Antineoplastic Agents)
- A liposomal combination of daunorubicin, an anthracycline topoisomerase inhibitor, and cytarabine, a nucleoside metabolic inhibitor, that is indicated for the treatment of adults with newly-diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC).
Selenious Acid – 40:12 (Replacement Preparations)
- Trace element
Inotuzumab Ozogamicin (Besponsa^®) – 10:00 (Antineoplastic Agents)
- Treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).

FDA MedWatch Alerts

Increased risks associated with the use of pembrolizumab (Keytruda) in combination with dexamethasone and an immunomodulatory agent (lenalidomide or pomalidomide) for the treatment of patients with multiple myeloma.
- Affected monographs:
  - 315018,”Pembrolizumab”,”10:00″
Obeticholic acid (Ocaliva) is being incorrectly dosed in some patients with moderate to severe decreases in liver function, resulting in an increased risk of serious liver injury and death.
- Affected monographs:
  - 316059,”Obeticholic Acid”,”56:92″
Avoid taking the potassium-lowering drug sodium polystyrene sulfonate (Kayexalate) at the same time as other medicines taken by mouth.
- Affected monographs:
  - 382108,”Sodium Polystyrene Sulfonate”,”40:18.18″
Opioid addiction medications buprenorphine and methadone should not be withheld from patients taking benzodiazepines or other drugs that depress the central nervous system (CNS).
- Affected monographs:
  - 382134,”Methadone”,”28:08.08″
  - 387004,”Buprenorphine”,”28:08.12″