Monthly Archives: May 2022

• Caprelsa (vandetanib) – for cancer
• Viibryd (vilazodone hydrochloride) – for depression

Adverse reactions or quality problems experienced with the use of a recalled product can be reported to the FDA’s MedWatch Adverse Event Reporting Program online, by mail, or by fax.

• Submit a Report Online:

https://www.accessdata.fda.gov/scripts/medwatch/index.cfm

• Send a Report Via U.S. Mail or Fax:

Download a form from https://www.fda.gov/safety/reporting-serious-problems-fda/forms- reporting-fda or call 1-800-332-1088 to request a reporting form. Then complete and return to the address on the form or submit by fax to 1-800-FDA-0178.

Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.

*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.

Evrysdi® (risdiplam) has received expanded approval to treat spinal muscular atrophy (SMA) in patients of all ages. It was previously indicated for patients two months of age and older.

• SMA is a rare, progressive neuromuscular disorder that can affect a person’s ability to walk, eat, and breathe. Evrysdi, made by Genentech, first received FDA approval to treat SMA in 2020.
• Under the recommended dosing, Evrysdi should be given via oral syringe once daily after a meal. The dosage strength is based on the patient’s age and body weight:
  • Less than two months old:15mg/kg
  • Two months to less than two years old: 0.2mg/kg
  • At least two years old and weighing less than 20kg: 0.25mg/kg
  • At least two years old and weighing at least 20kg: 5mg

The U.S. FDA has approved Kymriah® (tisagenlecleucel – Novartis) to treat relapsed or refractory follicular lymphoma in adults who have already received at least two lines of systemic therapy.

• Fist FDA approved in 2017, Kymriah is also indicated to treat:
  • B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse in patients up to 25 years; and
  • Relapsed or refractory large B-cell lymphoma in adults who have already received at least two lines of systemic therapy.
• Kymriah is a CAR-T therapy produced using the patient’s own immune. The cells are modified in a lab to specifically target cancer. For follicular lymphoma in adults, the recommended dose is 0.6 to 6.0 x 10⁸ CAR-positive viable T cells.

Bristol Myers Squibb’s Opdivo® (nivolumab) has received two new indications to treat esophageal squamous cell carcinoma (ESCC).

• Under the new indications, Opdivo is approved as a first-line treatment for unresectable advanced or metastatic ESCC in adults, regardless of their PD-L1 status, when used in combination with:
  • Fluoropyrimidine- and platinum-containing chemotherapy, or o Yervoy® (ipilimumab – Bristol Myers Squibb).
• Opdivo is administered via intravenous infusion, with treatment for ESCC continuing until acceptable toxicity or disease progression occur, or up to two years. The recommended dosing for ESCC treatment is:
  • Opvido 240mg every two weeks or 480mg every four weeks when used in combination with fluoropyrimidine- and platinum-containing chemotherapy.
  • Opdivo 3mg/kg of the patient’s body weight every two weeks or 360mg every three weeks when used with Yervoy 1mg/kg every six weeks.

Amneal Pharmaceuticals and Kashiv Biosciences have received FDA approval for Fylnetra® (pegfilgrastim-pbbk), a biosimilar of Amgen’s Neulasta® (pegfilgrastim).

• Fylnetra is the fifth Neulasta biosimilar approved in the United States. It is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients who have nonmyeloid malignancies and are receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.
• Recommended dosing is based on the patient’s weight. Fylnetra is given subcutaneously once per chemotherapy cycle. It should not be given between 14 days before or 24 hours after administration of cytotoxic chemotherapy.
• Launch and pricing information for Fylnetra are not yet available.

The U.S. FDA has approved Tibsovo® (ivosidenib – Servier) for use in combination with azacitidine to treat newly diagnosed IDH1-mutated acute myeloid leukemia (AML) in adults who are at least 75 years old or have comorbidities that preclude use of intensive induction chemotherapy.

• Tibsovo is also indicated to treat relapsed or refractory AML and locally advanced or metastatic cholangiocarcinoma. It first received FDA approval in 2018.
• Recommended dosing is 500mg of Tibsovo taken by mouth once daily until disease progression or unacceptable toxicity occur. Patients should avoid taking Tibsovo with a high fat meal, as it can affect how the medication works.

The U.S. FDA has approved Tyvaso DPI™ (treprostinil) inhalation powder to treat pulmonary arterial hypertension (PAH; WHO Group 1) and pulmonary hypertension associated with interstitial lung disease (PH-ILD; WHO Group 3) to improve exercise ability.

• Tyvaso DPI is the only FDA-approved dry powder inhaler for PAH and PH-ILD. It is a new formulation of treprostinil, the active pharmaceutical ingredient of Tyvaso® inhaled solution. Both products are made by United Therapeutics.
• Recommended dosing for Tyvaso DPI is one 16mcg cartridge per treatment session to start, titrated up to a target maintenance dose of 48mcg to 64mcg per session. The recommended dosing frequency is four separate treatment sessions each day, set approximately four hours apart, during waking hours.
• The medication has launched with a wholesale acquisition cost (WAC) of $20,906.09 for a 28-day supply of the maintenance dose.

Vtama® (tapinarof) 1% cream has been approved to treat plaque psoriasis in adults.

• Vtama is the first novel topical treatment for plaque psoriasis to receive FDA approval in 25 It is also the first steroid-free topical medication in its class.
• Recommended dosing is a thin layer of cream applied to the affected area once daily.
• Manufacturer Dermavant Sciences has launched the product at a wholesale acquisition cost (WAC) of $1,325 per 60g tube.

Teva Pharmaceuticals has recalled one lot of Anagrelide Capsules, USP 0.5mg, due to dissolution failure during routine stability testing. The affected capsules belong to Lot #GD01090.

• There is no impact to members through Benecard Central
• Anagrelide capsules are indicated to treat thrombocythemia (secondary to myeloproliferative neoplasms) to reduce the elevated platelet count and risk of thrombosis as well as ameliorate associated symptoms, including thrombo-hemorrhagic events.
• If anagrelide capsules fail to properly dissolve, this may decrease the drug’s effectiveness. This could have lift-threatening consequences for seriously ill As of the recall date, Teva had received no quality complaints or reports of adverse events of this nature for the affected lot.
• Teva advises patients who have questions or concerns to first consult with their healthcare provider. For medical-related questions or to report an adverse event, Teva Medical Information can be reached at 1-888-838-2872 (option 3, then option 4) or druginfo@tevapharm.com. For product quality complaint-related questions, Teva Quality Assurance Services can be reached at 1-888-838-2872 (option 4).
• The S. FDA has published the full recall notice on its website.

Vidaza® (azacytidine) is now approved to treat newly diagnosed juvenile myelomonocytic leukemia (JMML), a rare form of blood cancer, in pediatric patients who are at least one month old.

• Manufactured by Celgene, Vidaza first received FDA approval in 2004. In addition to treating JMML, it is also indicated to treat certain subtypes of myelodysplastic syndrome (MDS) in Both MDS and JMML occur when normal blood cell production is disrupted.
• Vidaza for JMML is administered via intravenous infusion once daily for seven days in a 28-day cycle, with patients receiving a minimum of three cycles and a maximum of The recommended dosing for JMML is:
  • 5mg/kg of the patient’s body weight for patients one month to less than one year old or weighing less than 10kg (22 pounds).
• 75mg/m² of the patient’s body surface area for patients at least one year of age who weigh 10kg or more.