Updates from FDA
New Drugs
LONAPEGSOMATROPIN-TCGD
(SKYTROFA—Ascendis Pharma)
Drug class: Human growth hormone.
Indication: Pediatric patients who are at least 1 year of age who are experiencing growth failure caused by an inadequate secretion of endogenous growth hormone.
Recommended dosage and administration: Skytrofa is administered subcutaneously once weekly and is dosed based on the patient’s weight (0.24 mg/kg). Skytrofa is supplied as a single-dose auto-injector and is available in 9 different strengths/doses. Administration should be supervised and monitored by an experienced physician.
Common adverse effects: Increased risk of viral infection, fever, cough, nausea/vomiting, diarrhea, abdominal pain, arthralgia, arthritis, hemorrhage (bloody nose, bruising, petechiae).
Warnings and precautions: Serious hypersensitivity reactions, increased risk of neoplasms, glucose intolerance, intracranial hypertension, fluid retention, hypoadrenalism, hypothyroidism, slipped capital femoral epiphysis, progression of preexisting scoliosis, pancreatitis.
TICK-BORNE
ENCEPHALITIS VACCINE
(TICOVAC—Pfizer Ireland Pharmaceuticals)
Drug class: Vaccine.
Indication: Prevention of tick-borne encephalitis (TBE). Ticovac is intended for use by patients who are at least 1 year old and live in or are traveling to an area where TBE is endemic.
Recommended dosage and administration: Vaccine should be brought to room temperature and shaken well before administration. Intended for intramuscular use only. Dose is based on age—0.25 mL per dose for patients who are 1 to 15 years old and 0.5 mL per dose for patients who are 16 years and older. Patients will receive a total of 3 doses (dosing schedule based on age, see full prescribing information for details).
Common adverse effects: Injection site tenderness and pain, fatigue, fever, headache, and muscle pain.
Warnings and precautions: Patients with altered immune systems may have a reduced immune response. Ticovac contains albumin and carries a potential risk of viral diseases and variant Creutzfeldt-Jakob disease (no cases have ever been reported or identified).
New Indication
RIVAROXABAN
(Xarelto—Jannsen Pharmaceuticals, Inc.)
Drug class: Factor Xa inhibitor.
Indication: New indication was approved for Xarelto in combination with aspirin to reduce risk of major thrombotic vascular events in patients with peripheral artery disease (PAD), including patients who have recently undergone a lower extremity revascularization procedure due to symptomatic PAD.
Recommended dosage and administration: 2.5 mg twice daily in addition to aspirin (75 mg–100 mg) once daily. For the indication of PAD, no adjustment is needed for renal impairment.
Common adverse effects: Bleeding is the most reported adverse effect.
Boxed warning: Premature discontinuation increases risk of thrombotic events. Patients receiving neuraxial anesthesia or undergoing spinal puncture are at risk of developing a spinal or epidural hematoma—risk versus benefits should be considered prior to performing a neuraxial intervention in patients taking Xarelto.
Warnings and precautions: Increased risk of bleeding, should be used with caution in pregnant patients due to risk of pregnancy-related hemorrhage, not recommended for patients with prosthetic heart valves or increased risk of thrombosis in patients with triple positive antiphospholipid syndrome.
LENVATINIB MESYLATE
(Lenvima—Esai Inc.)
Drug class: Kinase inhibitor.
Indication: Two new indications were approved over the past 2 months. In combination with pembrolizumab, Lenvima is now indicated for palliative treatment of advanced endometrial carcinoma that is not microsatellite instability-high or mismatch repair deficient in patients who continue to have cancer progression after previous systemic therapy. It also received approval in combination with pembrolizumab for treatment of adult patients with advanced renal cell carcinoma.
Recommended dosage and administration: For both new indications, the dose for Lenvima is 20 mg orally every day while pembrolizumab is administered intravenously once every 3 weeks.
Common adverse effects: Some adverse effects vary based on type of cancer. Adverse effects that have a greater than 20% incidence in both endometrial carcinoma and renal cell carcinoma include fatigue, diarrhea, hypothyroidism, musculoskeletal pain, decreased appetite, proteinuria, abdominal pain, hemorrhagic events, constipation, and palmar-plantar erythrodysesthesia.
Warnings and precautions: Large number of warnings and precautions, see label for a comprehensive list.
New Formulation
PALIPERIDONE PALMITATE
(Invega Hafyera—Janssen Pharmaceuticals, Inc.)
Drug class: Atypical antipsychotic.
Indication: Schizophrenia in adults.
Recommended dosage and administration: In this newly approved formulation, patients can receive an injection every 6 months if they have previously been adequately treated with a once-a-month paliperidone extended–release injectable for at least 4 months or an every-3-month paliperidone extended-release injectable for at least one 3-month cycle. At this time, the 2 doses that are available are 1,092 mg and 1,560 mg. Initial dosing with the 6-month injectable is based on previous injectable dose (see full prescribing information for exact conversions).
Common adverse effects: Upper respiratory tract infection, injection site reaction, weight increase, headache, and parkinsonism.
Boxed warning: Increased mortality in elderly patients with dementia-related psychosis.
Warnings and precautions: Avoid use with drugs that increase QT interval; monitor for hyperglycemia, diabetes, high cholesterol, and weight gain; potential for cognitive and motor impairment; other warnings and precautions exist—see prescribing information for more information.
Pfizer’s Comirnaty is the first official COVID-19 vaccine with full FDA approval
The Pfizer-BioNTech vaccine was first given emergency use approval (EUA) for patients 16 years of age and older in December 2020 and for patients who are 12 to 15 years old in May 2021.
Although the vaccine only received official approval for patients who are at least 16 years old, the EUA is still in place for patients aged 12 to 15. Comirnaty is administered as an intramuscular injection in a series of two 0.3 mL doses—doses are separated by 3 weeks.
The most commonly reported adverse reactions are injection site pain, fatigue, headache, muscle pain, chills, joint pain, fever, and injection site swelling. FDA has a rigorous process for reviewing vaccines and looked at effectiveness data from approximately 40,000 individuals and safety data from approximately 44,000 individuals. The overall data showed an efficacy rate of 91% in preventing COVID-19 disease.
FDA approves first-in-kind medication to treat moderate to severe pruritus
Pruritus can be a common adverse effect associated with hemodialysis. The itching may be caused by allergies or a high level of phosphorous.
Up to this point, there have been no treatments approved specifically for the treatment of pruritus associated with chronic kidney disease in adults undergoing hemodialysis, which was often treated with antihistamines or topical treatments.
Korsuva (difelikefalin acetate) is a kappa opioid receptor agonist, but the exact mechanism of action is unknown. It is administered as an intravenous bolus injection into the venous line of the dialysis circuit at the end of each hemodialysis treatment.
Dosing is 0.5 mcg/kg and it is supplied in a single-use vial—any amount that is left unused in vial should be discarded. The most commonly reported adverse effects are dizziness, sleepiness, mental status changes, and gait disturbances.
FDA expands labeling in Lexette
Lexette (halobetasol propionate) was only indicated for patients 18 years or older but FDA has now expanded labeling to include patients at least 12 years old.
Lexette is a topical foam formulation of halobetasol propionate—a steroid—and is indicated as a topical treatment for plaque psoriasis. It is generally used twice daily and should not be used for more than 2 weeks at a time.