"The U.S. Food and Drug Administration today approved TOBI Podhaler (tobramycin inhalation powder) for the management of cystic fibrosis
Cystic fibrosis is a genetic disease that affects about 30,000 pediatric and adult patients in the United "...
Hypersensitivity reactions have been reported in patients in clinical studies with VPRIV [see ADVERSE REACTIONS]. As with any intravenous protein product, hypersensitivity reactions are possible, therefore appropriate medical support should be readily available when VPRIV is administered. If a severe reaction occurs, current medical standards for emergency treatment are to be followed.
Treatment with VPRIV should be approached with caution in patients who have exhibited symptoms of hypersensitivity to the active ingredient or excipients in the drug product or to other enzyme replacement therapy.
Infusion-related reactions were the most commonly observed adverse reactions in patients treated with VPRIV in clinical studies. The most commonly observed symptoms of infusion-related reactions were: headache, dizziness, hypotension, hypertension, nausea, fatigue/asthenia, and pyrexia. Generally the infusion-related reactions were mild and, in treatment-na´ve patients, onset occurred mostly during the first 6 months of treatment and tended to occur less frequently with time.
The management of infusion-related reactions should be based on the severity of the reaction, e.g., slowing the infusion rate, treatment with medications such as antihistamines, antipyretics and/or corticosteroids, and/or stopping and resuming treatment with increased infusion time.
Pre-treatment with antihistamines and/or corticosteroids may prevent subsequent reactions in those cases where symptomatic treatment was required. Patients were not routinely pre-medicated prior to infusion of VPRIV during clinical studies.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term studies in animals to evaluate carcinogenic potential or studies to evaluate mutagenic potential have not been performed with velaglucerase alfa.
In a male and female fertility study in rats, velaglucerase alfa did not cause any significant adverse effect on male or female fertility parameters up to a maximum dose of 17 mg/kg/day (102 mg/m²/day, about 1.8 times the recommended human dose of 60 Units/kg/day based on the body surface area).
Use In Specific Populations
Pregnancy – Category B
Reproduction studies with velaglucerase alfa have been performed in pregnant rats at intravenous doses up to 17 mg/kg/day (102 mg/m²/day, about 1.8 times the recommended human dose of 60 Units/kg/day or 1.5 mg/kg/day or 55.5 mg/m²/day based on the body surface area). Reproduction studies have been performed in pregnant rabbits at intravenous doses up to 20 mg/kg/day (240 mg/m²/day, about 4.3 times the recommended human dose of 60 Units/kg/day based on the body surface area). These studies did not reveal any evidence of impaired fertility or harm to the fetus due to velaglucerase alfa.
A pre- and postnatal development study in rats showed no evidence of any adverse effect on pre- and postnatal development at doses up to 17 mg/kg (102 mg/m²/day, about 1.8 times the recommended human dose of 60 Units/kg/day based on the body surface area). There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, VPRIV should be used during pregnancy only if clearly needed.
There are no data from studies in lactating women. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when VPRIV is administered to a nursing woman.
The safety and effectiveness of VPRIV have been established in patients between 4 and 17 years of age. Use of VPRIV in this age group is supported by evidence from adequate and well-controlled studies of VPRIV in adults and pediatric [20 of 94 (21%)] patients. The safety and efficacy profiles were similar between pediatric and adult patients [see ADVERSE REACTIONS and Clinical Studies]. The safety of VPRIV has not been established in pediatric patients younger than 4 years of age.
In clinical studies, a total of 56 patients 65 years of age or older 10 of which were 75 years of age or older were treated with velaglucerase alfa. Among 205 patients who switched from imiglucerase to velaglucerase alfa, 52 patients were 65 years of age or older of which ten were 75 years and older. The adverse event profile in elderly patients was consistent with that previously observed across pediatric and adult patients. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be approached cautiously, considering potential comorbid conditions.
Last reviewed on RxList: 10/21/2013
This monograph has been modified to include the generic and brand name in many instances.
Additional VPRIV Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.