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The U.S. FDA has approved Pluvicto™ (lutetium Lu 177 vipivotide tetraxetan), a new radioactive therapeutic agent from Novartis, to treat prostate cancer. It has also approved an accompanying new indication for Locametz® (kit for the preparation of gallium Ga 68 gozetotide injection), an imaging agent also made by Novartis and first FDA approved in 2020.

• Pluvicto is indicated to treat adults who have prostate-specific membrane antigen (PSMA) positive metastatic castration-resistant prostate cancer. Patients must have undergone treatment with androgen receptor pathway inhibition and taxane-based chemotherapy.
• Locametz received a new indication for positron emission tomography (PET) of PSMA-positive lesions for selection of male patients who have metastatic prostate cancer and for whom Pluvicto PSMA-directed therapy is indicated.
• Both Pluvicto and Locametz should be used by or under the control of healthcare providers qualified in proper handling of radiopharmaceuticals. Recommended dosing is as follows:
  • Pluvicto: 7.4 GBq (200 mCi) once every six weeks, administered via intravenous injection or infusion, for up to six doses or until disease progression or unacceptable toxicity occur.
  • Locametz: 111 MBq to 259 MBq (3 mCi to 7 mCi) radioactivity, administered as a slow intravenous injection.
• Novartis has launched Pluvicto at a wholesale acquisition cost (WAC) of $42,500 per vial.

Nobelpharma’s Hyftor® (sirolimus) topical gel has been granted FDA approval to treat angiofibroma associated with tuberous sclerosis in patients who are at least three years old.

• Tuberous sclerosis is a rare genetic disorder that causes noncancerous but potentially life-threatening tumors. Most individuals diagnosed with the condition develop facial angiofibromas, which are growths made up of blood vessels and fibrous tissue.
• Hyftor is a topical formulation of sirolimus, a drug that first received FDA approval in 1999. Under the recommended dosing, it should be applied to the affected skin of the face twice daily. The maximum recommended daily dose is:
  • 600mg (2cm) for patients 6–11 years of age.
  • 800mg (2.5cm) for patients 12 years of age and older.
• Launch and pricing information are not yet available.

• 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.

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.

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.

Xarelto® (rivaroxaban) has been approved for two new pediatric indications. The FDA also approved a new oral suspension dosage form of the drug.

• Xarelto is now indicated for use in pediatric patients under 18 years of age to treat venous thromboembolism (VTE) and reduce the risk of recurrent VTE following at least five days of initial parenteral (injected or intravenous) anticoagulant treatment.
• It is also indicated to prevent blood clots and blood-clot related events in children at least two years of age who have congenital heart disease and have undergone the Fontan procedure (a type of open-heart surgery).
• Recommended dosing for pediatric patients is based on the patient’s weight and diagnosis. The medication should be taken with food to increase absorption into the body.
• Xarelto first received FDA approval in 2011 as an oral tablet and holds nine additional indications to treat or prevent problems caused by blood clots such as pulmonary embolism, deep vein thrombosis, and strokes.

ANI Pharmaceuticals has announced U.S. FDA approval of the company’s Purified Cortrophin™ Gel (repository corticotropin injection). The product is indicated to treat certain rheumatic disorders, collagen diseases, dermatologic diseases, allergic states, ophthalmic diseases, respiratory diseases, proteinuria, and acute exacerbations of multiple sclerosis.

• Recommended dosing is based on factors that include the indication, severity of disease, and general medical condition of the patient. Purified Cortrophin Gel is administered either subcutaneously or intramuscularly and can be self-administered or administered by a caregiver.
• ANI Pharmaceuticals plans to launch the drug during the first quarter of 2022. Pricing is not yet available.