ADVERTISEMENT
Search

ADVERTISEMENT
 

Pharmacy Today logo

New and Approved
Roger Selvage 1031

New and Approved

Previous Article Previous Article Managing motion sickness
Next Article GLP-1 agonists are changing the landscape of achieving optimum weight GLP-1 agonists are changing the landscape of achieving optimum weight

Updates from FDA

New indication

PEMBROLIZUMAB
(Keytruda—Merck Sharp & Dohme)

Drug class: Keytruda is a PD-1 blocking antibody.

Indication: Keytruda is now indicated for the treatment of patients with FIGO 2014 stage III–IVA cervical cancer in addition to previous indications for the treatment of melanoma, non-small cell lung cancer, head and neck squamous cell cancer, classical Hodgkin lymphoma, primary mediastinal large B-cell lymphoma, urothelial cancer, microsatellite instability or mismatch repair deficient cancer, microsatellite instability-high or mismatch repair deficient colorectal cancer, gastric cancer, esophageal cancer, recurrent or metastatic cervical cancer, hepatocellular carcinoma, biliary tract cancer, Merkel cell carcinoma, renal cell carcinoma, endometrial carcinoma, tumor mutational burden-high cancer, cutaneous squamous cell carcinoma, and triple-negative breast cancer as well as an additional treatment for adult classical Hodgkin lymphoma and adult primary mediastinal large B-cell lymphoma.

Recommended dosage and administration: The recommended dosage varies according to the cancer being treated; see drug label for appropriate dosage. Keytruda is administered via I.V. infusion over 30 minutes after dilution.

Common adverse effects: The most common adverse reactions to Keytruda as a single agent were fatigue, musculoskeletal pain, rash, diarrhea, pyrexia, cough, decreased appetite, pruritus, dyspnea, constipation, pain, abdominal pain, nausea, and hypothyroidism.

Warnings and precautions: Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue. Monitor for early identification of adverse effects and management. In the case of infusion-related reactions, interrupt, slow, or permanently discontinue infusion. Fatal or serious complications can occur in patients who receive allogeneic HSCT before or after being treated with a PD-1/PD-L1 blocking antibody. Treatment of patients with multiple myeloma with a PD-1 or PD-L1 blocking antibody in combination with a thalidomide analogue plus dexamethasone is not recommended outside of controlled clinical trials. Keytruda can cause fetal harm. Advise patients of the potential risk to a fetus and to use an effective method of contraception.

BUPIVACAINE, MELOXICAM
(Zynrelef Kit—Heron Therapeutics, Inc.)

Drug class: Zynrelef is an NSAID.

Indication: Zynrelef kits are now indicated for postsurgical analgesia in adults for up to 72 hours after soft tissue and orthopedic surgical procedures in addition to previous indications.

Recommended dosage and administration: The recommended dosage is up to a maximum dosage of 400 mg bupivacaine and 12 mg meloxicam. It is applied without a needle into the surgical site following final irrigation and suction but prior to suturing. See full prescribing information for full preparation, administration, and dosage instructions.

Common adverse effects: The most common adverse reaction to Zynrelef kits in soft tissue procedures was vomiting; the most common adverse reactions in orthopedic procedures were constipation and headache.

Boxed warning: NSAIDs cause an increased risk of serious CV thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use. Zynrelef is contraindicated in coronary artery bypass graft surgery. NSAIDs cause an increased risk of serious GI adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use or without warning symptoms. Older adult patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at a greater risk for serious GI events.

Other warnings and precautions: Monitor CV and respiratory vital signs and the patient’s state of consciousness after application. If abnormal liver tests persist or worsen, perform a clinical evaluation of the patient. Patients taking NSAIDs may have an impaired response to antihypertensives; monitor BP. Avoid use in patients with severe heart failure unless the benefits of using Zynrelef are expected to outweigh the risk of worsening heart failure. Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia. Avoid use in patients with advanced renal disease unless benefits are expected to outweigh risk of worsening renal function. Limit exposure to articular cartilage due to the potential risk of chondrolysis. Limit use of NSAIDs, including Zynrelef, between about 20 and 30 weeks of pregnancy due to risk of oligohydramnios/fetal renal dysfunction. Avoid the use of NSAIDs in patients who are ≥30 weeks’ pregnant due to risk of oligohydramnios/fetal renal dysfunction and premature closure of the ductus arteriosus. Monitor heboglobin or hematocrit in patients with any signs or symptoms of anemia.

ALPELISIB
(Piqray—Novartis)

Drug class: Piqray is a kinase inhibitor.

Indication: Piqray is indicated in combination with fulvestrant for the treatment of adults with hormone receptor (HR)–positive, human epidermal growth factor receptor 2 (HER2)–negative, PIK3CA-mutated, advanced, or metastatic breast cancer as indicated by an FDA-approved test following progression on or after an endocrine-based regimen. The indication has expanded to include pre- and perimenopausal women.

Recommended dosage and administration: The recommended dose of Piqray is 300 mg taken orally once daily with food.

Common adverse effects: The most common adverse reactions to Piqray were increased or decreased glucose, increased creatinine, diarrhea, rash, decreased lymphocyte count, increased gamma-glutamyl transferase, nausea, increased ALT, fatigue, decreased hemoglobin, increased lipase, decreased appetite, stomatitis, vomiting, decreased weight, decreased calcium, prolonged activated partial thromboplastic time, alopecia, and uveitis.

Warnings and precautions: In cases of severe hypersensitivity, permanently discontinue Piqray and initiat appropriate treatment. Piqray can cause severe cutaneous adverse reactions (SCARs). Interrupt Piqray use if there are signs or symptoms of SCARs and permanently discontinue if SCARs are confirmed. Piqray can cause severe hyperglycemia; before initiation, test fasting plasma glucose, A1C, and optimize blood glucose. Consider premedication with metformin before initiation of Piqray. Piqray can cause severe pneumonitis and interstitial lung disease; monitor for clinical symptoms or radiological changes and interrupt or discontinue Piqray if severe pneumonitis occurs. Diarrhea may be severe, resulting in potential dehydration and acute kidney injury; advise patients to start antidiarrheal treatment and notify their health care provider if diarrhea occurs. Monitor for symptoms of diarrhea or colitis. Advise patients of potential risk to a fetus and to use effective contraception. Avoid coadministration with a strong CYP3A4 inducer or breast cancer resistance protein inhibitor.

DUPILUMAB
(Dupixent—Regeneron Pharmaceuticals)

Drug class: Dupixent is an interleukin-4 receptor alpha antagonist.

Indication: Dupixent is now indicated for the treatment of eosinophilic esophagitis in adults and pediatric patients 1 year and older who weigh at least 15 kg in addition to previous indications for the treatment of atopic dermatitis in adult and pediatric patients 6 months and older, as an add-on maintenance treatment for asthma in adult and pediatric patients 6 years and older with moderate to severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid dependent asthma, as an add-on treatment of chronic rhinosinusitis with nasal polyposis in adults, and prurigo nodularis in adults.

Recommended dosage and administration: The recommended dose of Dupixent for eosinophilic esophagitis is 200 mg injected every other week for patients who weigh 15 kg to <30 kg, 300 mg every other week for patients weighing 30 kg to <40 kg, and 300 mg every week for patients weighing ≤40 kg. For other conditions, see label.

Common adverse effects: The most common adverse reaction to Dupixent for eosinophilic esophagitis were injection site reactions, respiratory tract and herpes viral infections, and arthralgia.

Warnings and precautions: When using Dupixent for eosinophilic conditions, watch for vasculitic rash, worsening pulmonary symptoms, and/or neuropathy, especially when reducing oral corticosteroids. See label for full list of warnings and precautions.

CEFAZOLIN INJECTION
(Baxter Healthcare Corporation)

Drug class: Cefazolin is a cephalosporin antibacterial.

Indication: Cefazolin injection is indicated for the treatment of respiratory tract infections, UTIs, skin and skin structure infections, biliary tract infections, bone and joint infections, genital infections, septicemia, and endocarditis. It is now also indicated for perioperative prophylaxis in adults and pediatric patients at least 10 years old.

Recommended dosage and administration: Cefazolin is administered via I.V. injection. For perioperative prophylaxis in adults, the dosage is 1 g to 2 g 0.5 to 1 hour prior to surgery, 500 mg to 1 g during lengthy procedures, and 500 mg to 1 g every 6 to 8 hours for 24 hours after the operation. For pediatric patients, the dosage is 1 g for patients who weigh <50 kg and 2 g for patients who weight ≥50 kg 0.5 to 1 hour prior to surgery, then 500 mg to 1 g during lengthy procedures, then 500 mg to 1 g every 6 to 8 hours for 24 hours after the operation. Dosage adjustment is required for adults with CLcr of <55 mL/min and children with a CLcr of <70 mL/min. For other indications, see prescribing label.

Common adverse effects: In adult patients, the most common adverse reactions were GI and allergic reactions. In pediatric patients, the most common adverse reactions were nausea, infusion site pain, and headache.

Warnings and precautions: Hypersensitivity may occur in up to 10% of patients with a history of penicillin allergy. Mild diarrhea to fatal colitis may occur. Cefazolin may be associated with a fall in prothrombin activity; prothrombin time should be monitored in patients at risk and exogenous vitamin K
administered as indicated. ■

Share

Print

Documents to download

ADVERTISEMENT