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Jakafi® (ruxolitinib) is now FDA approved to treat chronic graft-versus-host disease (cGVHD) in patients who are at least 12 years old and have failed treatment with one or two lines of systemic therapy.

• Graft-versus host disease occurs when stem cells from donated bone marrow attack healthy cells in the recipient’s body. It can be acute (occurring within 100 days of the transplant) or chronic (occurring 100 days or more after the transplant).
• In addition to treating cGVHD, Jakafi is also indicated to treat acute graft-versus-host disease, polycythemia vera (a type of blood cancer), and intermediate or high-risk myelofibrosis (a type of bone marrow cancer).
• The recommended starting dose for the new indication is 10mg taken by mouth twice daily. The daily dose may need to be reduced based on patient response and other clinical
• Jakafi, which is made by Incyte, first received FDA approval in

Opzelura™ (ruxolitinib) cream, manufactured by Incyte, has won U.S. FDA approval to treat mild to moderate atopic dermatitis in non-immunocompromised patients ages 12 years and up.

• Indicated for short-term and non-continuous chronic treatment, Opzelura is approved only for use in patients whose disease is not adequately controlled with other topical prescription therapies or for whom those therapies are inadvisable. It is the first topical formulation in a drug class known as JAK inhibitors to receive FDA approval.
• Recommended dosing is a thin layer applied to affected areas of the skin twice daily. The cream should not be used on more than 20% of the body surface and no more than 60g should be used per week.
• Opzelura has a wholesale acquisition cost (WAC) of $1,950 per 60g tube.

Dalvance® (dalbavancin – AbbVie) has received expanded U.S. FDA approval to treat acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible strains of Gram- positive microorganisms in patients of all ages. It was previously approved for use only in patients at least 18 years of age.

Acute infections of the skin and skin structures caused by bacteria affect an estimated 14 million people in the United States each year and are responsible for over 3 million emergency room visits. On average, hospitalization for ABSSSI lasts four days. Children with ABSSSI, which can be life-threatening, account for 3 million pediatric visits to doctors or emergency rooms annually.

In a clinical trial, 97.3% of pediatric patients (from newborns to less than 18 years of age) receiving a single dose of Dalvance had an early clinical response to treatment compared to 86.7% of patients receiving a current standard of care. Safety data was similar to that seen in adults receiving Dalvance.

Recommended dosing is based on individual patient factors, including age and creatinine clearance (a measure of kidney health). Dalvance is administered over the course of 30 minutes via intravenous infusion. Adults can receive either a single- or a two-dose regimen, with doses given one week apart for a two-dose regimen. Only a single-dose regimen is FDA approved for pediatric patients.

The FDA first approved Dalvance in 2014.

The U.S. FDA has approved Rezipres® (ephedrine hydrochloride injection), manufactured by Eton Pharmaceuticals, to treat clinically important hypotension occurring in the setting of anesthesia.

Hypotension, or low blood pressure, can occur under anesthesia due to factors such as blood loss or anesthesia side effects. It can put patients at risk regardless of whether they receive general anesthesia, in which a patient is unconscious during a procedure, or anesthesia that prevents pain without rendering a patient unconscious, such as an epidural used for C-sections.

In clinical studies, ephedrine produced increases in blood pressure in patients under general anesthesia or neuraxial anesthesia – when local anesthetics are used around the nerves of the central nervous system. Examples of neuraxial anesthesia include epidural, spinal, and caudal anesthesia.

Recommended dosing is an initial dose of 4.7mg to 9.4mg of Rezipres administered by intravenous (IV) bolus (a rapid IV injection) followed by additional boluses as needed. Dosage should be titrated according to the blood pressure goal. Total dosage should not exceed 47mg.

Launch and pricing information are not yet available.

Viona Pharmaceuticals, Inc., has recalled two lots of Metformin Hydrochloride Extended- Release Tablets, USP 750mg due to the detection of N-nitrosodimethylamine (NDMA) impurities above acceptable daily limits. Cadila Healthcare Limited manufactured the product in November 2019 for Viona to distribute.

NDMA is considered a probable human carcinogen (a substance that could cause cancer) and is a known environmental contaminant found in water and food. According to the recall announcement, patients who may have the affected metformin in their possession should not stop taking their medication without consulting a healthcare professional. The risk of stopping treatment with metformin, which is used to treat type 2 diabetes, may outweigh the risk of potential NDMA exposure. As of the date of the recall, Cadila and Viona had not received reports of adverse events related to the affected product.

Consumers can direct questions regarding the recall to Eversana Life Science Services at 1-888-304-5022 (option 1). They should contact their healthcare provider if they’ve experienced any problems that may be related to using the product and can also direct medical-related questions or report adverse events or quality issues to Viona at 1-888-304-5011. Adverse events can be reported to the U.S. FDA through the agency’s MedWatch program.

A full copy of the recall announcement with details of the affected lots is available on the FDA’s website.

There is no member impact through Benecard Central Fill.

The U.S. FDA has approved an expanded indication for Zipsor® (diclofenac potassium), manufactured by Assertio Therapeutics, to provide relief of mild to moderate acute pain in patients who are at least 12 years old. Zipsor first received FDA approval in 2009 for use in adults.

While diclofenac potassium, the active pharmaceutical ingredient (API) of Zipsor, is available as an API in other drugs, Zipsor comes in a proprietary, immediate release, liquid-filled gelatin capsule 25mg dosage form. It is not interchangeable with other dosage strengths or formulations of oral diclofenac potassium.

Recommended dosing is one capsule taken by mouth four times daily. A black box warning cautions that nonsteroidal anti-inflammatory drugs (NSAIDs) such as Zipsor can increase the risk of serious, potentially fatal cardiovascular and gastrointestinal (GI) events such as heart attack, stroke, GI ulcers and bleeding, and perforation of the stomach or intestines.

The U.S. FDA has approved AVEO Pharmaceuticals’ Fotivda® (tivozanib) to treat relapsed or refractory advanced renal cell carcinoma (RCC) in adults who have had two or more prior systemic therapies. It is the first FDA-approved therapy for this indication.

Renal cell carcinoma is the most common form of kidney cancer and is most often diagnosed in individuals between 50 and 70 years old. The risk of RCC is increased by certain factors such as smoking, dialysis treatment, hepatitis C infection, cystic kidney disease, certain genetic conditions, and chronic abuse of certain prescription and/or over-the-counter medications. Patients whose disease is advanced following at least two prior lines of systemic therapy can be faced with limited treatment options and a poor prognosis.

In a clinical study, Fotivda delivered an objective response rate (ORR) of 18%, median progression free survival (PFS) of 5.6 months, and median overall survival (OS) of 16.4 months. It was compared to treatment with sorafenib, a current standard of care, which delivered an 8% ORR, median PFS of 3.9 months, and median OS of 19.2 months.

Recommended dosing with Fotivda is 1.34mg taken by mouth once daily with or without food for 21 days, followed by seven days off treatment, in a 28-day cycle that should be repeated until disease progression or unacceptable toxicity occur. Dose modification may be necessary if the patient has hepatic impairment and/or experiences adverse reactions.

AVEO plans to launch Fotivda March 31, 2021. Pricing is not yet available.

Merck, the manufacturer of Keytruda® (pembrolizumab), has voluntarily withdrawn the drug’s FDA-approved indication to provide third-line treatment of metastatic small cell lung cancer (SCLC) in patients whose disease has progressed on or after platinum-based chemotherapy and at least one other prior line of therapy.

The indication was granted accelerated FDA approval in June 2019. Continued approval was contingent upon completion of a post-marketing requirement to establish the superiority of treatment with Keytruda based on overall survival (OS) rates in a clinical study. Although Keytruda met a study endpoint for progression-free survival, it did not meet the OS endpoint.

This change affects only the indication for third-line treatment of metastatic SCLC. It does not affect the approval of Keytruda’s more than two dozen other indications for cancer treatment.

Keytruda’s SCLC withdrawal follows a similar move by Bristol Myers Squibb. The manufacturer had been granted accelerated FDA approval for Opdivo® (nivolumab) in 2018 to provide third-line treatment for SCLC that had progressed after platinum-based chemotherapy and at least one other line of therapy. Like Keytruda, Opdivo did not meet the OS endpoint in a confirmatory trial. Bristol Myers Squibb voluntarily withdrew Opdivo’s third-line SCLC indication at the end of 2020.

The U.S. FDA has approved Arazlo™ (tazarotene) lotion 0.045%, manufactured by Ortho Dermatologics. The product is indicated to provide topical treatment of acne vulgaris in patients who are at least nine years of age. Although the active ingredient has been FDA approved since 1997, Arazlo is the first tazarotene acne treatment available in a lotion form.

Acne is the most common skin condition seen in the United States, affecting up to 50 million people. It occurs when skin cells and oil become trapped in hair follicles. This can cause cysts, nodules, pimples, whiteheads, and blackheads. In some cases, the disease can be painful due to inflammatory lesions, and it can also cause scarring and significant emotional distress.

In a clinical study, Arazlo was found to have similar treatment success compared to Tazorac® (tazarotene – Allergan) Cream 0.1%, with fewer treatment-related adverse events. Only 2.9% of patients treated with Arazlo experienced an adverse event, compared to 5.6% with Tazorac. The lotion formulation may help patients tolerate Arazlo better than other tazarotene treatments due to the hydrating ingredients included in the formulation. Recommended dosing is a thin layer of Arazlo applied to affected areas once daily. Contact with the eyes, mouth, paranasal creases, and mucous membranes should be avoided.

Ortho Dermatologics plans to launch the product in the first half of 2020 but has not yet announced pricing plans.

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 issued a warning that serious breathing difficulties may occur in patients who have respiratory risk factors and use the medications gabapentin or pregabalin. Risk factors include advanced age, respiratory diseases such as chronic obstructive pulmonary disease (COPD) that reduce lung function, and concomitant use with central nervous system (CNS) depressants such as antidepressants, anxiolytics, and antihistamines.

Gabapentin and pregabalin, known collectively as gabapentinoids, are FDA-approved to treat a variety of conditions such as nerve pain, seizures, and restless leg syndrome. Gabapentin is available as a brand name medication (Neurontin®, Gralise®, Horizant®) and as a generic. Pregabalin is sold under the brand names Lyrica® and Lyrica® CR. Lyrica, but not Lyrica CR, became available as a generic in 2019.

To address the potential risks involved in the use of gabapentinoids, the FDA is requiring new warnings be added to the drugs’ prescribing information. The agency has also required manufacturers to conduct new clinical trials to further evaluate the drugs’ abuse potential. The misuse and abuse of gabapentinoids in combination with opioids has increased in recent years. The use of these classes of drugs together may raise the chances of serious respiratory difficulties.

Patients or their caregivers should seek immediate medical attention in the event of serious respiratory problems, as these can be life-threatening. Signs and symptoms include dizziness, shortness of breath, confusion, extreme lethargy, unresponsiveness, and bluish skin – especially on the lips, fingers, and toes. Healthcare professionals should prescribe gabapentinoids at the lowest possible dose. They should also carefully monitor elderly patients, patients who have underlying respiratory disease, and patients who also take a CNS depressant. Patients who meet these criteria should be advised of the risks and how to identify respiratory depression.

Further information regarding the warning can be found at the FDA’s website. Patients, caregivers, and healthcare providers are encouraged to report adverse events that may be related to the use of gabapentinoids to the FDA’s MedWatch program.

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.