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FDA approves second Remicade biosimilar

The FDA has approved infliximab-abda (Renflexis), a second biosimilar to Johnson & Johnson's infliximab (Remicade), for immune and inflammatory conditions, including rheumatoid arthritis, adult and pediatric Crohn disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis. The biosimilar must show it has no clinically meaningful differences in terms of safety and effectiveness from the reference product. The FDA states that only minor differences are allowed in biosimilar products.

 

Renflexis is a tumor-necrosis factor-alpha inhibitor administered as a weight-based I.V. infusion. Doses greater than 5 mg/kg are contraindicated in patients with moderate-to-severe heart failure. The drug should not be readministered to patients who experience a severe hypersensitivity reaction. Labeling includes a boxed warning for an increased risk of serious infections (including tuberculosis and invasive fungal infections) and an increased risk of lymphoma and other malignancies.

 

The most common adverse reactions are upper respiratory infections, sinusitis, pharyngitis, headache, abdominal pain, and infusion-related reactions.

 

New nasal spray approved for opioid overdose

Naloxone (Narcan) nasal spray has been approved by the FDA as a 2 mg formulation for the emergency treatment of known or suspected opioid overdose as manifested by respiratory and/or central nervous system depression. The 2 mg dose is an opioid antagonist approved for use in opioid-dependent patients expected to be at risk for severe opioid withdrawal in situations where there is a low risk for accidental or intentional opioid exposure by household contacts.

 

Naloxone nasal spray is a ready-to-use and needle-free version of naloxone that provides emergency treatment of opioid overdose, including prescription opioid analgesics and heroin-related overdose. It is not a substitute for emergency medical care, which should be sought immediately after initial use, keeping the patient under continued surveillance.

 

Expanded indications approved for migraine prevention

The FDA has approved expanded indications for topiramate extended-release capsules (Trokendi XR) to include use as a prophylaxis for migraine headaches in patients ages 12 years and over. Trokendi XR is an extended-release formulation of topiramate. The drug was originally approved as an antiepileptic drug.

  
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Trokendi XR is taken orally once daily. The capsule must be swallowed whole and intact. The capsule should not be sprinkled on food, chewed, or crushed. Contraindications include recent alcohol use (within 6 hours before and 6 hours after taking Trokendi XR) and use in patients with metabolic acidosis who are also taking metformin. Patients should be monitored for suicidal ideation and behavior.

 

The most common adverse reactions in clinical trials for migraine prophylaxis include paresthesia, anorexia, weight loss, difficulty with memory, changes in taste, upper respiratory tract infections, abdominal pain, diarrhea, hypoesthesia, and nausea.

 

New anabolic treatment for postmenopausal women with osteoporosis

The FDA has approved abaloparatide (Tymlos) subcutaneous injection for postmenopausal women with osteoporosis who are at high risk for fracture due to a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have not responded to or are intolerant to other available osteoporosis therapy. Tymlos, which is a human parathyroid hormone-related peptide analogue, is the first new anabolic treatment approved for use in postmenopausal women with osteoporosis in the United States in nearly 15 years.

  
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The drug is administered subcutaneously once daily. Patients should receive supplemental calcium and vitamin D if their dietary intake is inadequate. Labeling for Tymlos contains a boxed warning noting that the drug caused a dose-dependent increase in the incidence of osteosarcoma in rats. It is unknown if Tymlos will cause osteosarcoma in humans; however, its use is not recommended in patients at increased risk for osteosarcoma, including those with Paget disease of bone and other conditions discussed on the product labeling.

 

Cumulative use of Tymlos and parathyroid hormone analogues for more than 2 years during a patient's lifetime is also not recommended.