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New and Approved
Roger Selvage 475

New and Approved

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Updates from FDA

New drugs

ETRASIMOD

(Velsipity—Pfizer Inc.)

Drug class: Velsipity is a sphingosine 1-phosphate receptor modulator.

Indication: Velsipity is indicated for the treatment of moderately to severely active ulcerative colitis in adults.

Recommended dosage and administration: Assessments are required prior to initiating Velsipity. The recommended dosage is 2 mg orally once daily.

Common adverse effects: The most common adverse reactions are headache, elevated liver levels, and dizziness.

Warnings and precautions: Velsipity is contraindicated in patients who have experienced myocardial infarction, unstable angina pectoris, stroke, transient ischemic attack, decompensated heart failure requiring hospitalization, or Class III or IV heart failure in the last 6 months. It is also contraindicated for those with a history or presence of Mobitz type II second-degree or third-degree atrioventricular (AV) block, sick sinus syndrome, or sino-atrial block, unless the patient has a functioning pacemaker.

Velsipity may increase the risk of infections. Obtain a complete blood count before initiation of treatment. Monitor for infection during treatment and for 5 weeks after discontinuation. Consider interruption of treatment if a serious infection develops. Avoid use of live attenuated vaccines during and for up to 5 weeks after treatment. Treatment with Velsipity may result in a transient decrease in heart rate and AV conduction delays. Obtain an ECG to assess for preexisting cardiac conduction abnormalities before starting treatment. Consider cardiology consultation for conduction abnormalities or concomitant use with other drugs that decrease heart rate. Elevations of transaminases may occur. Obtain transaminase and bilirubin levels before initiating Velsipity. Discontinue if significant liver injury is confirmed.

Velsipity may increase the risk of macular edema. Obtain a baseline evaluation of the fundus, including the macula, near the start of treatment. Periodically conduct an evaluation of the fundus, including the macula, while on therapy and any time there is a change in vision. Consider discontinuing Velsipity if macular edema develops. Monitor BP during treatment. Velsipity may cause fetal harm. Advise patients of reproductive potential of the potential risk to a fetus and to use effective contraception during treatment and for 1 week after stopping Velsipity. Obtain a skin examination prior to or shortly after the start of treatment and periodically during treatment, especially if risk factors are present. Promptly evaluate suspicious skin lesions. If symptoms of posterior reversible encephalopathy syndrome develop, obtain a physical and neurological exam, and consider MRI. Velsipity may cause a decline in pulmonary function. Assess pulmonary function if clinically indicated. Consider the half-life and mode of action of prior therapies as unintended additive immune system effects from prior treatment with immunosuppressive or immune-modulating drugs may occur. If using concomitant immunosuppressants, monitor patients for infectious complications for up to 5 weeks after the last dose of Velsipity. Use is not recommended in severe hepatic impairment.

ZILUCOPLAN

(Zilbrysq—UCB Inc.)

Drug class: Zilbrysq is a complement inhibitor.

Indication: Zilbrysq is indicated for the treatment of generalized myasthenia gravis in adult patients who are anti-acetylcholine receptor antibody positive.

Recommended dosage and administration: Obtain baseline amylase and lipase. Zilbrysq should be administered by S.C. injection only. The recommended dosage is 16.6 mg in patients who weigh <56 kg, 23 mg in patients who weigh 56 kg to <77 kg, and 32.4 mg in patients who weigh ≥77 kg.

Common adverse effects: The most common adverse reactions were injection site reactions, upper respiratory tract infection, and diarrhea.

Boxed warning: Life-threatening and fatal meningococcal infections have occurred in patients treated with complement inhibitors. Meningococcal infection may become rapidly life-threatening or fatal if not recognized and treated early. Complete or update meningococcal vaccination at least 2 weeks prior to administering the first dose of Zilbrysq unless the risk of delaying therapy outweighs the risk of developing a meningococcal infection. Comply with the most current ACIP recommendations for meningococcal vaccinations in patients receiving a complement inhibitor. Persons receiving Zilbrysq are at increased risk for invasive disease caused by Neisseria meningitidis, even if they develop antibodies following vaccination. Monitor patients for early signs of meningococcal infections and evaluate immediately if infection is suspected. Zilbrysq is only available through a restricted program called REMS.

Other warnings and precautions: Zilbrysq is contraindicated in patients with unresolved N. meningitidis infection. Use caution when administering Zilbrysq to patients with any other systemic infection. Pancreatitis and pancreatic cysts have been reported in patients treated with Zilbrysq. Discontinue Zilbrysq in patients with suspected pancreatitis and initiate appropriate management until pancreatis is ruled out or has resolved. Use in pregnancy may cause fetal harm.

New formulations

ACETAMINOPHEN AND IBUPROFEN

(Combogesic I.V.—AFT Pharmaceuticals)

Drug class: Acetaminophen is a nonopiate, nonsalicylate analgesic. Ibuprofen is an NSAID.

Indication: Combogesic I.V. is indicated in adults where an I.V. route of administration is clinically necessary for the relief of mild to moderate pain or the management of moderate to severe pain as an adjunct to opioid analgesics. Combogesic I.V. is indicated for short-term use of 5 days or fewer.

Recommended dosage and administration: The lowest effective dosage for the shortest duration consistent with individual patient treatment goals should be used. Do not exceed the maximum total daily dose of Combogesic I.V. (4,000 mg acetaminophen and 1,200 mg ibuprofen) in 24 hours. Do not exceed a total daily dose of 4,000 mg of acetaminophen from all sources. Do not administer with other acetaminophen-containing products. For adult patients weighing ≥50 kg (actual body weight), the recommended dosage is 1,000 mg of acetaminophen and 300 mg of ibuprofen administered as a 15-minute infusion every 6 hours, as necessary. For adult patients weighing <50 kg (actual body weight), the recommended dosage is 15 mg/kg acetaminophen and 4.5 mg/kg ibuprofen administered as a 15-minute infusion every 6 hours, as necessary.

Common adverse effects: The most common adverse reactions are infusion site pain, nausea, constipation, dizziness, infusion site extravasation, vomiting, headache, and somnolence.

Boxed warning: Take care when prescribing, preparing, and administering Combogesic I.V. to avoid dosing errors, which could result in accidental overdose and death. Combogesic I.V. contains acetaminophen, which has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with doses of acetaminophen that exceed 4,000 mg per day, and often involve more than one acetaminophen-containing product. NSAIDs, such as the ibuprofen in Combogesic I.V., may cause an increased risk of serious cardiovascular 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. Combogesic I.V. is contraindicated in the setting of coronary artery bypass graft (CABG) surgery. NSAIDs, such as the ibuprofen in Combogesic I.V., cause an increased risk of serious GI adverse events, including bleeding, ulcerations, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and those with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.

Other warnings and precautions: Combogesic I.V. is contraindicated in patients who have previously demonstrated hypersensitivity to acetaminophen, ibuprofen, other NSAIDs, or to any of the excipients in the I.V. formulation, patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs, patients with severe hepatic impairment or severe active liver disease, and in the setting of CABG surgery. Patients taking some antihypertensive medications may have impaired response to these therapies when taking NSAIDs.

Monitor BP. Avoid use of Combogesic I.V. in patients with severe heart failure unless benefits are expected to outweigh risks of worsening heart failure. Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury. Discontinue use immediately if anaphylactic symptoms occur. Combogesic I.V. is contraindicated in patients with aspirin-sensitive asthma. Monitor patients with pre-existing asthma. Discontinue Combogesic I.V. at first appearance of skin rash or other signs of hypersensitivity. If a drug rash with eosinophilia and systemic symptoms occurs, discontinue treatment and evaluate clinically. Limit use of NSAID-containing products between about 20 weeks to 30 weeks in pregnancy due to the risk of oligohydramnios/fetal renal dysfunction. Avoid use of NSAID-containing products at about 30 weeks’ gestation and later in pregnancy due to the risks of oligohydramnios/fetal renal dysfunction and premature closure of the fetal ductus arteriosus. Monitor hemoglobin or hematocrit in patients with any signs or symptoms of anemia. Combogesic I.V. is not recommended in patients with renal or hepatic impairment. A number of known or potential interactions between Combogesic I.V. and other drugs/drug classes exist.

New combinations

CLINDAMYCIN PHOPHATE, ADAPALENE, AND BENZOYL PEROXIDE

(Cabtreo—Bausch Health)

Drug class: Cabtreo is a combination of a lincosamide antibacterial, a retinoid, and benzoyl peroxide.

Indication: Cabtreo is indicated for the topical treatment of acne vulgaris in adult and pediatric patients 12 years and older.

Recommended dosage and administration: Apply a thin layer of Cabtreo to the affected areas once daily. Avoid the eyes, mouth, paranasal creases, mucous membranes, and areas of broken, eczematous, or sunburned skin. Cabtreo is not for oral, ophthalmic, or intravaginal use.

Common adverse effects: The most common adverse reactions were application site reactions, pain, erythema, dryness, irritation, exfoliation, and dermatitis.

Warnings and precautions: Cabtreo is contraindicated in known hypersensitivity to clindamycin, adapalene, benzoyl peroxide, and components of the formulation or lincomycin, and history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis. If a serious hypersensitivity reaction occurs, discontinue Cabtreo immediately and initiate appropriate therapy. Clindamycin can cause severe colitis, which may result in death. Discontinue Cabtreo if diarrhea occurs. Avoid or minimize exposure to sunlight and sunlamps. Wear sunscreen and protective clothing when sun exposure cannot be avoided. Erythema, scaling, dryness, stinging/burning, and irritant and allergic contact dermatitis may occur with use of Cabtreo and may necessitate discontinuation. Use Cabtreo with caution in patients receiving neuromuscular blocking agents. ■

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