Monthly Archives: July 2022

• Keveyis (dichlorphenamide) – for hyperkalemic (elevated potassium) paralysis
• Kinevac (sincalide) – for diagnosis of gallbladder and pancreatic disorders and imaging of the intestines
• Vibvativ (telavancin) – for severe bacterial skin infections and hospital- or ventilator- associated bacterial pneumonia

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 an expanded indication for Rebinyn® [coagulation factor IX (recombinant), glycopegylated]. The product is now indicated for routine prophylaxis to reduce the frequency of bleeding episodes in adults and children who have hemophilia B (congenital factor IX deficiency).

• Originally FDA approved in 2017, Rebinyn is also indicated for use in adults and children who have hemophilia B to provide on-demand treatment and control of bleeding episodes, as well as perioperative management of bleeding.
• The recommended dosing for routine prophylaxis is 40 IU/kg of the patient’s body weight administered via intravenous injection once weekly.

Zoryve™ (roflumilast – Arcutis Biotherapeutics) has obtained FDA approval as a topical treatment for plaque psoriasis, including for intertriginous areas (skin folds), in patients who are at least 12 years old.

• Under the recommended dosing, Zoryve is applied once daily to affected areas of the skin.
• Arcutis Biotherapeutics has launched Zoryve at a wholesale acquisition cost (WAC) of $825 per 60g tube.

Benlysta® (belimumab – GSK) has received an expanded indication to treat active lupus nephritis in patients who are at least five years old and receiving standard therapy.

• In 2011 Benlysta was given FDA approval for treatment of systemic lupus erythematosus and lupus nephritis treatment in It has now been indicated to treat both active systemic lupus erythematosus and lupus nephritis in patients who are at least five years old and receiving standard therapy.
• Recommended dosing is based on the patient’s age, diagnosis, and weight.

Samsung Bioepis Co., Ltd. and Organon & Co. (NYSE: OGN) announced the FDA approval of the citrate-free, high-concentration (100 mg/mL) formulation of HADLIMA™ (adalimumab-bwwd), a biosimilar referencing HUMIRA^® (adalimumab). HADLIMA will be available in pre-filled syringes and autoinjector options. The autoinjector was specifically designed with the patient in mind.

• Hadlima is the fourth FDA approved biosimilar to adlimumbad
• It is a tumor necrosis factor (TNF) blocker for Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Crohn’s Disease, and Ulcerative Colitis.
• Planned launch in the S. is in 2023

Incyte’s Opzelura™ (ruxolitinib) cream has been approved for the topical treatment of nonsegmental vitiligo in patients who are at least 12 years old. Vitiligo is an autoimmune condition that destroys melanocytes, leading to depigmentation of the skin.

• This is the second indication for the drug, which has been FDA approved since 2011 for the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in certain patients at least 12 years of age.
• Recommended dosing for vitiligo is a thin layer of cream applied twice daily to affected areas of up to 10% of the body’s surface area.

Avadel Pharmaceuticals’ Lumryz™ (sodium oxybate) has been tentatively approved to treat cataplexy and excessive daytime sleepiness (EDS) caused by narcolepsy.

• Lumryz is a once-nightly formulation of sodium oxybate, whereas the currently available sodium oxybate formulations, Xyrem and Xywav, are taken twice nightly, requiring middle-of-the-night dosing.
• Launch and pricing information are not yet Avadel noted that Lumryz could be granted final approval on or before June 2023.

Zonisade™ (zonisamide oral suspension) has received FDA approval to provide adjunctive therapy for the treatment of partial onset seizures in patients who are at least 16 years old.

• Zonisade is a new formulation of the active pharmaceutical ingredient (API) zonisamide. An oral capsule formulation, approved for use in adults and sold by Concordia under the brand name Zonegran®, received FDA approval in The oral capsule version is also available as a generic.
• Recommended dosing for Zonisade is 100mg daily. This can be increased by 100mg daily every two weeks, based on clinical response and tolerability, to 400mg daily. Patients who tolerate treatment at 400mg daily and require further reduction of seizures may have their dosage increased up to a maximum of 600mg daily.
• Eton Pharmaceuticals, the manufacturer, has not yet announced launch or pricing plans for Zonisade.

Pfizer’s Xalkori® (crizotinib) has received a new indication to treat unresectable, recurrent, or refractory ALK-positive inflammatory myofibroblastic tumors (IMT) in patients who are at least one year of age.

• IMTs are a rare form of tumor that, while usually noncancerous, can cause significant health problems depending on their location.
• Xalkori first received FDA approval in 2011 and is also approved to treat certain patients who have non-small cell lung cancer or systemic anaplastic large cell lymphoma.
• Recommended dosing for IMT treatment is:
  • Adults: 250mg by mouth twice daily until disease progression or unacceptable toxicity.
  • Pediatric Patients: 280mg/m² of body surface area taken by mouth twice daily until disease progression or unacceptable toxicity.

Diacomit® (stiripentol) is now indicated for use with clobazam to treat seizures associated with Dravet syndrome in patients at least six months of age and weighing at least 7kg (15.4 pounds).

• First FDA approved in 2018, Diacomit was originally indicated only for use in patients at least two years of age.
• Recommended daily dosing is 50mg/kg of the patient’s weight, divided into two to three doses and taken by mouth with water during a For patients who weigh less than 10kg (22 pounds), dosing frequency should not exceed twice daily. For all patients, daily dosing should not exceed 3,000mg.