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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.

Krystexxa® (pegloticase – Horizon Therapeutics) has received an expanded indication for co-administration with methotrexate to treat chronic gout in adults whose disease is refractory to conventional therapy.

• First FDA approved in 2010, Krystexxa was originally as a single therapy to treat gout. Gout is an inflammatory condition that causes uric acid to crystallize and form deposits in the joints.
• Recommended dosing under the expanded indication is 8mg of Krystexxa given as an intravenous infusion once every two weeks, co-administered with weekly oral methotrexate (15mg once a week week) and folic acid or folinic acid supplementation.
  • Methotrexate and folic acid or folinic acid supplementation should be started at least four weeks prior to initiating Krystexxa.
  • Krystexxa can be used alone in patients for whom methotrexate is contraindicated or not clinically appropriate.

Comirnaty® (COVID-19 vaccine, mRNA – Pfizer and BioNTech) is now FDA approved for use in adolescents who are 12-15 years old. This age group was previously eligible to receive Comirnaty under emergency use authorization (EUA).

• Under its newly expanded indication, the vaccine is approved to prevent COVID-19 caused by the SARS-CoV-2 virus in individuals 12 years of age and older.
• Recommended dosing for ages 12-15 is a two-dose primary vaccination series, with a third dose recommended for individuals with certain types of immunocompromise. The age group is also eligible under EUA to receive a booster dose at least five months after completing a primary vaccination series. If a patient has certain types of immunocompromise, a second booster dose may also be appropriate.
• Comirnaty has been in use in the United States under EUA since December 2020, and first received FDA approval in August 2021.

Mylan Pharmaceuticals has recalled one batch of Insulin Glargine (insulin glargine-yfgn) Injection, 100 units/mL (U-100), 3mL prefilled pens. The product is packaged in cartons of five pens and is being recalled due to the potential for missing labels on some pens.

• There is no impact to members through Benecard Central Fill.
• Insulin glargine is indicated to improve glycemic control in adults who have type 1 or type 2 diabetes and pediatric patients who have type 1 A missing label on insulin glargine pens could lead to a mix-up of products/strengths if a patient uses more than one type of insulin. This could cause potentially dangerous high or low blood sugar. As of the recall date, Mylan had received no reports of related adverse events.
• Mylan advises patients to contact Sedgwick at 1-877-643-8438 for the documentation packet to return the product if they have unlabeled insulin glargine Questions regarding this recall can be directed to Viatris Customer Relations at 1-800-796-9526 or customer.service@viatris.com. Mylan recommends patients contact a healthcare provider if they have experienced any problems that may be related to using the recalled product.
• Full recall details are available on the S. FDA’s website.

The U.S. FDA has revised emergency use authorization (EAU) for Pfizer’s Paxlovid™ (nirmatrelvir and ritonavir) to allow state-licensed pharmacists to prescribe the drug to eligible patients, within certain limitations.

• The FDA recommends that patients first consider obtaining care from their regular healthcare provider or a Test-to-Treat site in their area.
• If a patient has tested positive for COVID-19 and wishes to obtain a Paxlovid prescription from a pharmacist, the FDA advises them to bring the following information to determine their eligibility to receive the medication:
  • Electronic or printed health records less than 12 months old. These should include the most recent reports of laboratory blood work for the pharmacist to review for kidney or liver problems. A pharmacist can also obtain this information through consultation with the patient’s healthcare provider.
  • A list of all medications the patient is taking, including over the counter (OTC) products, so the pharmacist can screen for potentially serious drug-to-drug interactions.

• The pharmacist should refer patients for clinical evaluation with a physician, advanced practice registered nurse, or physician assistant licensed or authorized under state law to prescribe drugs, if any of the following apply:
  • Sufficient information is not available to assess renal and hepatic function or to assess for a potential drug interaction.
  • Modification of other medications is needed due to a potential drug interaction.
  • Paxlovid is not an appropriate therapeutic option based on the current Fact Sheet for Healthcare Providers or due to potential drug interactions for which recommended monitoring would not be feasible.
• Paxlovid is authorized to treat mild-to-moderate COVID-19 in adults and pediatric patients (at least 12 years old and weighing at least 40kg, or 88 pounds) who are at high risk for progression to severe COVID-19 and have positive results of direct SARS-CoV-2 viral testing (including OTC at- home tests).