Posts in category: Uncategorized

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.

Vonjo™ (pacritinib) has received U.S. FDA approval to treat intermediate or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis in adults who have a platelet count below 50 × 10⁹/L.

• Vonjo is a novel oral kinase inhibitor that acts against enzymes in the body that may contribute to myelofibrosis, a rare bone marrow cancer. In myelofibrosis, scar tissue replaces healthy bone marrow and interferes with production of red blood cells, white blood cells, and platelets.
• Recommended dosing is two 100mg capsules taken twice daily by
• CTI BioPharma, the manufacturer, has announced that Vonjo will be available at a wholesale acquisition cost (WAC) of $19,500 per month.

February 24, 2022 – Jardiance® (empagliflozin – Boehringer Ingelheim) is now indicated to reduce the risk of cardiovascular death and hospitalization for heart failure in adults who have heart failure.

• Initially FDA approved in 2014, Jardiance is also indicated as an adjunct to diet and exercise to improve glycemic control in adults who have type 2 diabetes, and to reduce the risk of cardiovascular death in adults who have type 2 diabetes and established cardiovascular disease.
• Recommended dosing is 10mg once daily in the morning. For adults who have type 2 diabetes and require additional glycemic control, the dose can be increased to 25mg per day.

The U.S. FDA has approved Mylan’s generic for Restasis® (cyclosporine ophthalmic emulsion) 0.05% single-use vials.

• Like Restasis, the generic is indicated to increase tear production when that production is believed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca (dry eye).
• Recommended dosing is one drop in each eye twice daily, approximately 12 hours apart.
• Brand name Restasis is manufactured by Allergan and first received FDA approval in 2002. It has a wholesale acquisition cost (WAC) of $645.63 per month. Mylan’s generic is available at a WAC of $588.82 per month.

FDA approves Xenoview (xenon Xe 129 hyperpolarized) for use with MRI for the Evaluation of Lung Ventilation

Polarean Imaging plc, the medical imaging technology company, announces that the U.S. Food and Drug Administration (“FDA”) has granted approval for its drug device combination product, Xenoview. Xenoview, prepared from the Xenon Xe 129 Gas Blend, is a hyperpolarized contrast agent indicated for use with magnetic resonance imaging (“MRI”) for the evaluation of lung ventilation in adults and pediatric patients aged 12 years and older. Xenoview has not been evaluated for use with lung perfusion imaging.

Xenoview expands the opportunity for pulmonary medicine to utilize the first and only inhaled MRI hyperpolarized contrast agent for novel visualization of lung ventilation without exposing patients to any ionizing radiation and its associated risks. The dose of Xenoview, created through the Polarean HPX hyperpolarization system, is administered in a single 10-15 second breath hold MRI procedure.

More than 30 million Americans suffer from a chronic lung disease, and there is a significant unmet need for non-invasive diagnostic technology. Xenoview can provide pulmonologists, surgeons, and other respiratory specialists with regional maps of ventilation in their patients’ lungs to assist them in managing their disease.

Xenoview is not approved for use in pediatric patients less than 12 years of age.

Read more…

Solosec® (secnidazole – Lupin Pharmaceuticals) now has an expanded indication to treat bacterial vaginosis and trichomoniasis in patients who are at least 12 years old.

• Solosec has been FDA approved for use in adults since 2017. Bacterial vaginosis describes inflammation in the vagina caused by bacterial overgrowth, while trichomoniasis is a sexually transmitted infection caused by a protozoan parasite.
• Recommended dosing is a single 2g packet of granules taken once by mouth, mixed with applesauce, yogurt, or pudding. If Solosec is being used to treat trichomoniasis, all sexual partners should receive the same dose at the same time.