Monthly Archives: March 2022

In accordance with a settlement agreement, Teva Pharmaceuticals has launched its generic for Bristol Myers Squibb’s Revlimid® (lenalidomide) in the United States. The FDA approved the generic on May 21, 2021.

• Like brand name Revlimid, Teva’s generic is indicated to treat:
  • Multiple myeloma when used in combination with
  • Transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with a deletion 5q abnormality, with or without additional cytogenetic abnormalities.
  • Mantle cell lymphoma that has relapsed or progressed following two prior therapies, one of which included bortezomib.
• Unlike Revlimid, the generic is not currently FDA approved for:
  • Use as a multiple myeloma maintenance therapy in patients who have undergone autologous hematopoietic stem cell transplantation.
  • Use in combination with a rituximab product to treat follicular lymphoma or marginal zone lymphoma in patients who have received prior treatment.
• Teva’s generic is available in 5mg, 10mg, 15mg, and 25mg capsules. Revlimid is available in two additional dosage strengths (2.5mg and 20mg capsules) for which no generic is currently available on the S. market. Recommended dosing for both the brand name and generic product is based on the indication.
• Revlimid has a wholesale acquisition cost (WAC) of $17,497.73 per four-week supply compared to $15,118.04 for Teva’s generic.

Bristol-Myers Squibb’s Opdivo® (nivolumab) has received a new indication for use with platinum-doublet chemotherapy to treat adult patients who have resectable (tumors ≥ 4cm or node positive) non-small cell lung cancer in the neoadjuvant setting.

• Recommended dosing under the new indication is 360mg of Opdivo given as an intravenous infusion with platinum-doublet chemotherapy on the same day once every three weeks for three treatment cycles.
• First FDA approved in 2014, Opdivo holds indications to treat over half a dozen forms of cancer, including multiple indications for treating non-small cell lung cancer.

The U.S. FDA has approved Aspruzyo Sprinkle™ (ranolazine – Sun Pharmaceuticals) to treat chronic angina (chest pain). The drug may be used in conjunction with beta-blockers, nitrates, calcium channel blockers, antiplatelet therapy, lipid-lowering therapy, angiotensin-converting enzyme inhibitors, and angiotensin receptor blockers.

• Recommended dosing is 500mg taken twice daily. Dosing can be increased to a maximum of 1,000mg twice daily if needed based on clinical symptoms.
• Aspruzyo Sprinkle is supplied in unit-dose sachets of 500mg or 1,000mg. Each sachet contains granules that are added on top of a tablespoon of soft food (such as applesauce or yogurt) for oral administration or given with water via nasogastric tube or gastric tube.
• Launch and pricing information are not available.

Janssen Pharmaceuticals’ Carvykti™ (ciltacabtagene autoleucel; cilta-cel) is FDA approved to treat relapsed or refractory multiple myeloma in adults who have received at least four prior lines of therapy including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

• Carvykti is a chimeric antigen receptor T-cell (CAR-T) therapy created using the patient’s own immune cells. T-cells are collected from the patient and modified in a lab to specifically target multiple myeloma cells, then infused back into the patient.
• A one-time intravenous treatment, Carvykti must be given at a certified healthcare
• The product has launched at a wholesale acquisition cost (WAC) of $465,000.

Releuko™ (filgrastim-ayow – Kashiv Biosciences) for subcutaneous or intravenous use is now FDA approved as a biosimilar for Neupogen® (filgrastim – Amgen).

• Releuko 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 significant incidence of severe neutropenia with fever.
  • Reduce the time to neutrophil recovery and the duration of fever following induction or consolidation chemotherapy treatment of patients who have acute myeloid leukemia.
  • Reduce the duration of neutropenia and neutropenia-related clinical sequelae (e.g.‚ febrile neutropenia) in patients who have nonmyeloid malignancies and are undergoing myeloablative chemotherapy followed by bone marrow transplantation.
  • Reduce the incidence and duration of sequelae of severe neutropenia (e.g., fever‚ infections‚ oropharyngeal ulcers) in symptomatic patients who have congenital neutropenia‚ cyclic neutropenia‚ or idiopathic neutropenia.
• Unlike Neupogen, Relueko has not received FDA approval to:
  • Mobilize autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis.
  • Increase survival in patients acutely exposed to myelosuppressive doses of radiation (hematopoietic syndrome of acute radiation syndrome).
• Recommended dosing for Releuko is based on the patient’s weight and the indication. If administration via subcutaneous injection rather than intravenous infusion is appropriate, Releuko can be given at home by a patient or caregiver trained in proper procedure.
• Although considered a therapeutic alternative for Neupogen, Releuko has not received FDA approval to be automatically interchanged for Neupogen at the pharmacy. Its wholesale acquisition cost (WAC) is $2,280 per syringe or vial.

• Arestin (minocycline hydrochloride) – for gum disease
• Abraxane (paclitaxel) – for cancer
• Cholbam (cholic acid) – for bile acid synthesis disorders and peroxisomal disorders
• Revlimid 5mg, 10mg, 15mg, 25mg (lenalidomide) – for cancer
• Vimpat (lacosamide) – for seizures
• Zipsor (diclofenac potassium) – for pain relief

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.