Updates from FDA
APhA Staff
New drugs
METHYLPHENIDATE HYDROCHLORIDE
(RELEXXII—Osmotica Pharmaceuticals)
Drug class: CNS stimulant.
Indication: Relexxii is indicated for treatment of ADHD in adults up to 65 years old and pediatric patients 6 years and older.
Recommended dosage and administration: For pediatric patients, starting dosage is 18 mg once daily. Dosage may be increased by 18 mg once per day at weekly intervals. Maximum dosage for pediatric patients is 54 mg once daily for patients 6 years to 12 years old and 72 mg once daily for patients 13 years to 18 years old.
For adult patients, starting dosage is 18 mg or 36 mg once daily. Dosage may be increased by 18 mg once daily at weekly intervals, with a maximum dosage of 72 mg once daily.
Administer once daily in the morning with or without food. Relexxii should be swallowed whole with liquid; it should not be chewed, divided, or crushed.
Common adverse effects: For pediatric patients: upper abdominal pain. For adults: decreased appetite, headache, dry mouth, nausea, insomnia, anxiety, dizziness, weight loss, irritability, and hyperhidrosis.
Black box warning: CNS stimulants have a high potential for abuse and dependence. Monitor for signs of abuse and dependence during therapy.
Other warnings and precautions: Relexxii is contraindicated with treatment with an MAOI and/or 14 days after use of an MAOI.
Sudden death has been reported with CNS-stimulant treatment in pediatric patients, and sudden death, stroke, and myocardial infarction have been reported with CNS-stimulant treatment in adults. Avoid use in patients with known heart abnormalities, cardiomyopathy, serious heart arrhythmias, or coronary artery disease.
Blood pressure and heart rate may increase. Relexxii may cause drug interactions with antihypertensive drugs. Monitor blood pressure and pulse. Use of stimulants may cause treatment-emergent psychotic or manic symptoms in patients with no prior history or exacerbations of symptoms in patients with pre-existing psychiatric illness. Evaluate for bipolar before use and monitor for aggressive behavior. Patients should seek immediate medical attention if priapism is observed.
CNS stimulants for treatment of ADHD are associated with peripheral vasculopathy, including Raynaud’s phenomenon; careful observation for digital changes is necessary.
Monitor height and weight at appropriate intervals for pediatric patients.
New indication
RISANKIZUMAB-RZAA
(SKYRIZI—Abbvie Inc.)
Drug class: Interleukin-23 antagonist.
Indication: Skyrizi was previously indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy, and for active psoriatic arthritis in adults. It is now indicated to also treat moderately to severely active Crohn’s disease in adults.
Recommended dosage and administration: For treatment of plaque psoriasis and psoriatic arthritis, dosage is 150 mg administered via subcutaneous injection at week 0, week 4, and every 12 weeks thereafter.
For patients with psoriatic arthritis, Skyrizi can be administered alone or in combination with nonbiologic disease-modifying antirheumatic drugs. For Crohn’s disease treatment, induction dosage is 600 mg via I.V. infusion over at least one hour at week 0, week 4, and week 8 of treatment, with a recommended maintenance dosage of 360 mg administered via S.C. injection at week 12 and every 8 weeks thereafter. Liver enzymes and bilirubin levels should be checked prior to initiating treatment.
Common adverse effects: For Crohn’s disease treatment, the most common adverse effects are upper respiratory infections, headache, and arthralgia during induction and arthralgia, injection site reactions, abdominal pain, anemia, pyrexia, back pain, arthropathy, and UTI during maintenance.
Warnings and precautions: Serious hypersensitivity reactions, including anaphylaxis, may occur.
Skyrizi may increase risk of infection; if an infection develops, do not administer until infection resolves. Evaluate for tuberculosis before initiating treatment. Avoid use of live vaccines during treatment.
In treatment of Crohn’s disease, drug-induced liver injury during induction has been reported. Monitor live enzymes and bilirubin levels at baseline and during induction up to at least 12 weeks of treatment; monitor according to routine patient management.
New generics
CABAZITAXEL
(Cabazitaxel—Breckenridge)
Drug class: Chemotherapy.
Indication: Cabazitaxel is indicated in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer previously treated with a docetaxel-containing treatment regimen.
Recommended dosage and administration: Cabazitaxel dosage is determined according to body surface area. It is administered as a one-hour infusion of 20 mg/m2 every 3 weeks in combination with a daily dose of oral prednisone 10 mg. A dose of 25 mg/m2 can be used in select patients at health care providers’ discretion; see full prescribing information.
As a premedication regimen, administer an antihistamine (dexchlorpheniramine 5 mg, diphenhydramine 25 mg, or equivalent), a corticosteroid (dexamethasone 8 mg or equivalent) and an H2 antagonist 30 minutes prior to each dose of cabazitaxel.
Common adverse effects: Neutropenia, anemia, diarrhea, nausea, fatigue, asthenia, vomiting, hematuria, constipation, decreased appetite, back pain, and abdominal pain are possible.
Black box warning: Neutropenic deaths have been reported. Blood cell count should be frequently checked. Hypersensitivity reactions can occur, including erythema, hypotension, and bronchospasm; use should be immediately discontinued if these symptoms occur.
Other warnings and precautions: Cabazitaxel is contraindicated in patients with ≤ 1,500 cells/mm3. Primary prophylaxis with granulocyte colony-stimulating factor is recommended in patients with high-risk clinical features and all patients receiving a dose of 25 mg/m2.
PVC equipment should not be used.
Elderly patients may experience increased toxicity; see full prescribing information.
Cabazitaxel should be reduced to a 20 mg/m2 dose for patients with mild hepatic impairment and a 15 mg/m2
dose for patients with moderate hepatic impairment.
Use of cabazitaxel with strong CYP3A inhibitors may cause increased plasma concentration of cabazitaxel.
Cabazitaxel may cause embryonic and fetal death and should not be administered to pregnant people.
ADAPALENE AND BENZOYL PEROXIDE
(Adapalene and benzoyl peroxide— Actavis Labs UT Inc.)
Drug class: Acne medication.
Indication: Adapalene and benzoyl peroxide is indicated for the treatment of acne.
Recommended dosage and administration: After the affected area is cleaned and dried, a thin layer should be applied and rubbed in using fingers. Hands should be washed with soap and water both before and after using the medicine.
Common adverse effects: Some patients may experience skin dryness/peeling; skin redness/flushing; blistering, burning, crusting, or flaking of skin; and application site reactions.
Warnings and precautions: Increased sensitivity to sunlight, wind, and cold weather reported. Patients should use sunscreen when outdoors and avoid sunlamps and tanning beds. Sun-protective clothing such as a hat may be helpful.
Skin reactions including dryness, redness, burning, or stinging can occur while using this medicine; application of a moisturizer may lessen these skin problems.
Irritating skin care products such as rough skin cleansers; hair removal products; drying soaps or cosmetics; or products containing alcohol, astringents, spices, or lime should be avoided while using this treatment.
Patients should not wax to remove hair on areas treated with this medicine.
Patients should allow this medicine to dry completely before getting dressed. It may cause bleaching of clothes and hair. ■
New dosage
On June 29, 2022, FDA revised the fact sheet for Evusheld (tixagevimab copackaged with cilgavimab—Astra Zeneca) in reponse to new nonclinical data and pharmacokinetic modeling on the drug’s ability to neutralize COVID-19 Omicron subvariants BA.2, BA.2.12.1, and BA.5.
The new recommendations suggest repeat dosing of Evusheld every 6 months, with a dose of 300 mg of tixagevimab and 300 mg cilgavimab if patients need ongoing protection. The previous fact sheet did not recommend a specific dosage. ■
Drug recall
On June 28, 2022, Bryant Ranch Prepack Inc. issued a voluntary consumer-level recall of one lot of morphine sulfate 30 mg extended-release tablets and one lot of morphine sulfate 60 mg extended-release tablets. The recalled products had incorrect labeling that designated the 30 mg tablets as containing 60 mg and vice-versa. This means patients prescribed a 30 mg dose may risk overdose, while patients prescribed a 60 mg dose may experience inadequate pain relief and withdrawal.
The 30 mg tablets are round and purple with “RD” and “71” debossed on one side, while the 60 mg tablets are round and light orange with “RD” and “72” debossed on one side.
At press time, the company is notifying distributors and customers and is arranging return of all recalled products. Consumers with questions are encouraged to contact Bryant Ranch Prepack Inc. by calling
(877) 885-0882 or emailing cs@brppharma.com. They should also contact their health care provider if they have experienced any problems that may be related to taking this drug. ■