Updates from FDA
APhA Staff
New Formulations
ABROCITINIB
(Cibinqo—Pfizer Inc.)
Drug class: Janus kinase inhibitor.
Indication: Cibinqo is indicated for patients who have refractory, moderate-to-severe atopic dermatitis that is not adequately controlled with their current therapy.
Recommended dosage and administration: Cibinqo is supplied as 50 mg, 100 mg, and 200 mg tablets. The recommended daily dose is 100 mg Cibinqo by mouth once daily and can be taken with or without food.
Tablets should not be crushed, split, or chewed. The dose can be increased to 200 mg by mouth once daily after 12 weeks if an adequate response has not occurred. If adequate response does not occur with 200 mg dose, the medication should be discontinued.
The recommended dose for patients with renal impairment (eGFR 30-59 mL/minute) is 50 mg by mouth once daily. Patients who have severe or end-stage renal disease or severe hepatic impairment should not take Cibinqo. During the first 3 months of treatment, concomitant use of antiplatelet therapy is contraindicated (except for aspirin 81 mg).
Prior to initiating Cibinqo therapy, there are several tests and evaluations that should be performed, including tuberculosis infection evaluation, viral hepatitis screening, and a complete blood count. See full prescribing details for more detailed information about testing prior to initiation of Cibinqo and modifications to make if the patient is a poor metabolizer of CYP2C19 or if they are taking a strong inhibitor of CYP2C19.
Common adverse effects: Some of the more common adverse effects include nasopharyngitis, nausea, headache, dizziness, fatigue, acne, and vomiting. See full prescribing information for full list of adverse effects.
Black box warning: Taking Cibinqo increases patients’ risk of serious infections (e.g., bacterial, fungal, and viral), mortality, malignancy, major adverse cardiovascular events, and thrombosis.
Additional warnings and precautions: Increased risk of hematologic abnormalities and lipid elevations. Patients who are initiating Cibinqo therapy should have a complete blood count prior to and 4 weeks after initiation of therapy as well as 4 weeks after any dose changes. Lipid levels should also be assessed prior to and 4 weeks after initiation of therapy.
DARIDOREXANT
HYDROCHLORIDE
(Quviviq—Idorsia Pharmaceuticals)
Drug class: Orexin receptor antagonist.
Indication: Quviviq is indicated for the treatment of insomnia in adults and can be used by people who experience trouble with sleep onset or people who experience trouble staying asleep.
Note: At the time of publication this medication was still awaiting controlled substance scheduling and will not be commercially available until the DEA has completed this process.
Recommended dosage and administration: The recommended dose is 25 mg or 50 mg Quviviq, by mouth, once daily. It should be taken at bedtime within 30 minutes of going to sleep. It is recommended that when taking Quviviq, patients should allow for at least 7 hours of uninterrupted sleep.
The prescribing information does not give any clarification on which dose should be started or when/how to decide to increase or decrease the dose.
If a patient has moderate hepatic impairment the maximum daily dose is 25 mg and, if they have severe hepatic impairment treatment with Quviviq is not recommended.
Taking the medication with food may delay onset of the medication—pharmacokinetic data suggest this delay may be approximately 60 minutes. Concomitant use of Quviviq with strong CYP3A4 inhibitors is not recommended as it is primarily metabolized via the CYP3A4 enzyme. Additionally, Quviviq is contraindicated for use in patients who have narcolepsy.
Common adverse effects: Headache, somnolence, fatigue.
Warnings and precautions: Patients who take this medication may continue to feel tired after they wake up. In clinical trials, patients’ driving ability was impaired in the morning hours after taking Quviviq—patients should be counseled on this.
Increased CNS depression is common when coadministered with alcohol, benzodiazepines, opioids, or tricyclic antidepressants.
Medication should be discontinued if complex sleep behaviors (i.e., sleepwalking, sleep-driving, preparing and eating food while asleep) occur.
See full prescribing information for entire list of warnings and precautions.
OLOPATADINE HYDROCHLORIDE/MOMETASONE FUROATE
(Ryaltris—Glenmark Pharmaceuticals)
Drug class: Olopatadine hydrochloride is a histamine-1 receptor inhibitor, mometasone furoate is a corticosteroid.
Indication: Ryaltris is indicated for patients 12 years and older for the treatment of seasonal allergic rhinitis.
Recommended dosage and administration: Ryaltris is supplied as a metered-dose nasal spray—each spray delivers 665 micrograms of olopatadine and 25 micrograms of mometasone.
The recommended dose is two sprays in each nostril twice daily—patients should shake the bottle well prior to administering each dose.
Each bottle contains a 30-day supply (240 metered sprays) and should be stored at room temperature.
Prior to first use, the bottle should be primed by shaking it well and releasing 6 sprays into the air (until a fine mist appears). If it has been more than 14 days since the product was used, it should be primed by shaking the bottle well and releasing 2 sprays into the air.
Common adverse effects: Dysgeusia (altered or impaired sense of taste), bloody nose, nasal discomfort.
Warnings and precautions: Patients have an increased risk of nosebleeds, nasal ulceration, impaired nasal wound healing, and localized Candida albicans infections.
Patients who take nasal corticosteroids may be at an increased risk for developing glaucoma or cataracts and should be monitored if there are any changes in vision or if the patient has a history of increased intraocular pressure, glaucoma, or cataracts.
New Indication
REMDESIVIR
(Veklury—Gilead Sciences, Inc.)
Drug class: SARS-CoV-2 nucleotide analog RNA polymerase inhibitor.
Indication: Previously indicated only for hospitalized patients, in January 2022, Veklury gained FDA approval for non-hospitalized patients with mild-to-moderate COVID-19 who are at risk of developing a severe COVID-19 infection.
It is indicated for use in patients who are at least 12 years old who weigh at least 40 kg and have tested positive for COVID-19.
Note: In January 2022, FDA also revised an EUA for Veklury. The EUA now authorizes use of Veklury for treatment of COVID-19 in pediatric patients who are less than 12 years old, weigh at least 3.5 kg, and are or are not hospitalized and at risk of progression to severe infection.
Recommended dosage and administration: All patients receiving Veklury treatment will receive a one-time loading dose of 200 mg Veklury on day one of treatment.
Following the loading dose, patients receive 100 mg Veklury once daily for the duration of treatment.
Patients who are hospitalized will generally receive 5 days total of treatment but can receive up to 10 days of treatment under certain circumstances.
Patients who are not hospitalized will receive a total of 3 days of treatment.
Veklury should only be administered by I.V. infusion and is supplied in two formulations: a 100 mg/20 mL solution and a 100 mg lyophilized powder.
See full prescribing information for specific reconstitution/preparation instructions as well as administration and infusion rate instructions.
eGFR must be obtained prior to Veklury administration and should also be monitored throughout treatment—if eGFR is less than 30 mL/minute, Veklury should not be administered.
Hepatic lab testing and prothrombin time should also be obtained prior to administration and monitored as necessary.
Common adverse effects: Nausea, increased alanine aminotransferase (ALT), increased aspartate aminotransferase (AST).
Warnings and precautions: Patients receiving Veklury may experience hypersensitivity reactions including infusion-related and anaphylactic reactions and should be monitored throughout their infusion as well as for at least an hour postinfusion.
Studies also show an increased risk of transaminase elevations—if ALT levels rise above 10 times the upper limit of normal, discontinuation of therapy should be considered.
Veklury shows a reduction in antiviral action when coadministered with chloroquine phosphate or hydroxychloroquine. ■
FDA approves COVID-19 vaccine for patients 18 years and older
On January 31, 2022, FDA gave full approval to Spikevax, also known as the Moderna COVID-19 vaccine. It is now the second fully FDA-approved COVID-19 vaccine. As of publication, it was approved for patients 18 years and older as a 2-dose series to be administered one month apart as a 0.5 mL intramuscular injection. It maintains EUA as a third dose for immunocompromised individuals as well as a single booster dose to be given at least 5 months after completion of the primary 2-dose series.
First medication for acute graft versus host disease
On December 15, 2021, FDA approved Orencia (abatacept) for the prevention of acute graft versus host disease (aGVHD). It is the first medication to gain FDA approval for this indication. GVHD is a rare condition where the donor cells attack the recipient’s body and can occur in patients who have undergone a bone marrow or stem cell transplant.
In clinical studies, patients who were treated with Orencia had a significantly higher overall survival rate when compared to patients who received placebo. Orencia is indicated as prophylactic treatment for patients who are at least two years old and undergoing hematopoietic stem cell transplantation and should be given in combination with a calcineurin inhibitor and methotrexate.
Orencia is administered as an I.V. infusion and is dosed based on age and weight. Administration occurs the day before transplantation (day -1) and on days 5, 14, and 28 after transplantation.
The most commonly reported adverse effects for use in aGVHD are anemia, hypertension, CMV reactivation/CMV infection, fever, pneumonia, bloody nose, a decrease in CD4 lymphocytes, hypermagnesemia, and acute kidney injury.