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New & Approved
Roger Selvage 1848

New & Approved

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New combination

Acetaminophen and ibuprofen

(Combogesic—AFT Pharmaceuticals)

Drug class: Combogesic is a combination of acetaminophen and ibuprofen, an NSAID.

Indication: Combogesic is indicated in adults for the short-term management of mild to moderate acute pain.

Recommended dosage and administration: The recommended dosage of Combogesic is 3 tablets every 6 hours as needed for pain relief, up to a maximum of 12 tablets per day. Each tablet contains 325 mg acetaminophen and 97.5 mg ibuprofen. Patients should use the lowest effective dose for the shortest duration possible that is consistent with the individual’s patient treatment goals.

Common adverse effects: The most common adverse reactions are nausea, vomiting, headache, dizziness, somnolence, postprocedural hemorrhage, and swelling of the face.

Boxed warning: Combogesic 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 cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction (MI) and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use. Combogesic tablets are contraindicated in the setting of coronary artery bypass 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 may occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.

Other warnings and precautions: Do not administer with other acetaminophen-containing products. Combogesic is contraindicated in patients with known hypersensitivity to acetaminophen, ibuprofen, other NSAIDs, or to any of the excipients in this product and patients with a history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients and in the setting of coronary artery bypass graft surgery. NSAID-containing products, including Combogesic, are associated with reversible infertility. Use is not recommended in patients with renal or hepatic impairment. Patients taking some antihypertensive medications may have impaired response to these therapies when taking NSAIDs. Monitor BP. Avoid use of Combogesic in patients with severe heart failure unless benefits are expected to outweigh the risk of worsening heart failure. Long-term administration of NSAIDs, including the ibuprofen component of Combogesic, has resulted in renal papillary necrosis and other renal injury. Monitor patients with pre-existing asthma. Serious skin reactions may occur; discontinue at first appearance of skin rash or other signs of hypersensitivity. Limit the use of NSAID-containing products, including Combogesic, between about 20 to 30 weeks of pregnancy due to the risk of oligohydramnios and premature closure of the fetal ductus arteriosus. Monitor hemoglobin or hematocrit in patients with any signs or symptoms of anemia. Drug interactions may occur with drugs that interfere with hemostasis, aspirin, ACE inhibitors, angiotensin receptor blockers, beta blockers, diuretics, digoxin, lithium, methotrexate, cyclosporine, other NSAIDs, salicylates, and pemetrexed.

New drugs

daprodustat

(Jesduvroq—GlaxoSmithKline)

Drug class: Jesduvroq is a hypoxia-inducible factor prolyl hydroxylase inhibitor.

Indication: Jesduvroq in indicated for the treatment of anemia due to chronic kidney disease in adults who have been receiving dialysis for at least 4 months.

Recommended dosage and administration: Jesduvroq should be administered once daily with or without food. The recommended starting dosage, dose titration, and monitoring varies based on hemoglobin level, liver function, and concomitant medication use. Jesduvroq is available as 1 mg, 2 mg, 4 mg, 6 mg, and 8 mg tablets.

Common adverse effects: The most common adverse reactions are hypertension, thrombotic vascular events, and abdominal pain.

Boxed warning: Jesduvroq increases the risk of thrombotic vascular events, including major adverse cardiovascular events. Targeting a hemoglobin level greater than 11 g/dL is expected to further increase the risk of death and arterial venous thrombotic events, as occurs with erythropoietin stimulating agents, which also increase erythropoietin levels. No trial has identified a hemoglobin target level, dose of Jesduvroq, or dosing strategy that does not increase these risks. Use the lowest dose of Jesduvroq sufficient to reduce the need for red blood cell transfusions.

Other warnings and precautions: Jesduvroq has not been shown to improve quality of life, fatigue, or patient well-being. It is not indicated for use as a substitute for transfusion in patients requiring immediate correction of anemia or in patients who are not on dialysis. If a patient is being treated with a moderate CYP2C8 inhibitor, reduce the starting dose of Jesduvroq. Monitor hemoglobin and adjust the dose of Jesduvroq as appropriate in patients taking CYP2C8 inducers. Jesduvroq may cause fetal harm in pregnancy. Breastfeeding is not recommended until one week after the final dose. Reduce the starting dose in patients with moderate hepatic impairment. Jesduvroq is not recommended in severe hepatic impairment. Jesduvroq is contraindicated with strong CYP2C8 inhibitors such as gemfibrozil or in uncontrolled hypertension. There is an increased risk of hospitalization for heart failure in patients with a history of heart failure. Worsening hypertension, including hypertensive crisis may occur. Monitor BP. Adjust antihypertensive therapy as needed. Gastric or esophageal erosions and GI bleeding have been reported. Jesduvroq may have unfavorable effects on cancer growth and is not recommended in active malignancy.

omaveloxolone

(Skyclarys—Reata Pharmaceuticals Inc.)

Drug class: Skyclarys is an Nrf2 transcription factor.

Indication: Skyclarys is indicated for the treatment of Friedreich’s ataxia in adults and adolescents 16 years and older.

Recommended dosage and administration: Obtain ALT, AST, bilirubin, B-type natriuretic peptide, and lipid parameters prior to initiating Skyclarys and during treatment. The recommended dosage is 150 mg (3 capsules) taken orally once daily. Skyclarys should be administered on an empty stomach at least 1 hour before eating. Capsules should be swallowed whole. The recommended dosage of Skyclarys is 100 mg once daily in patients with moderate hepatic impairment. If adverse reactions emerge, further reduce the dosage to 50 mg once daily. Avoid use in patients with severe hepatic impairment.

Common adverse effects: The most common adverse reactions are elevated liver enzymes, headache, nausea, abdominal pain, fatigue, diarrhea, and musculoskeletal pain.

Warnings and precautions: Skyclarys may cause fetal harm if used during pregnancy. Avoid concomitant use with moderate or strong CYP3A4 inhibitors. Advise patients of signs and symptoms of fluid overload.

New dosage form

atorvastatin calcium

(Atorvaliq—CMP Pharma)

Drug class: Atorvaliq is an HMG-CoA reductase inhibitor.

Indication: Atorvaliq is indicated to reduce the risk of MI, stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically relevant CHD, MI, and stroke in adults with type 2 diabetes with multiple risk factors for CHD but without clinically relevant CHD, nonfatal MI, fatal and nonfatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD. Atorvaliq is indicated as an adjunct to diet to reduce low-density lipoproteins (LDL-C) in adults with primary hyperlipidemia and adults with pediatric patients 10 years and older with heterozygous familial hypercholesterolemia. It is indicated as an adjunct to other LDL-Cs in adults and pediatric patients 10 years and older with homozygous familial hypercholesterolemia and as an adjunct to diet for the treatment of adults with primary dysbetalipoproteinemia or hypertriglyceridemia.

Recommended dosage and administration: In adults, the recommended starting dosage is 10 mg or 20 mg once daily on an empty stomach. Assess LDL-C when clinically appropriate, as early as 4 weeks after initiating Atorvaliq; adjust dosage if necessary. Dosing can be increased up to 80 mg once daily. Atorvaliq is packaged as a 20 mg/5 mL oral suspension.

Common adverse effects: The most common adverse reactions are nasopharyngitis, arthralgia, diarrhea, pain in extremity, and urinary tract infection.

Warnings and precautions: Atorvaliq may cause fetal harm if used during pregnancy, and breastfeeding is not recommended during treatment. Use is contraindicated in acute liver failure, decompensated cirrhosis, and hypersensitivity to atorvastatin or any excipient in Atorvaliq. Rifampin may reduce atorvastatin plasma concentrations. Atorvaliq may increase plasma levels of norethindrone, ethinyl estradiol, and digoxin. Myopathy and rhabdomyolysis may occur. Rare reports of immune mediated necrotizing myopathy have been reported with statin use. Increases in serum transaminases have occurred, some persistent. Rare reports of fatal and nonfatal hepatic failure have occurred. ■

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