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FUZEON
Overview
What is FUZEON?
FUZEON (enfuvirtide) is an inhibitor of the fusion of HIV-1 with CD4 cells. Enfuvirtide is a linear 36-amino acid synthetic peptide with the N-terminus acetylated and the C-terminus is a carboxamide. It is composed of naturally occurring L-amino acid residues.
Enfuvirtide is a white to off-white amorphous solid. It has negligible solubility in pure water and the solubility increases in aqueous buffers (pH 7.5) to 85-142 g/100 mL. The empirical formula of enfuvirtide is CHNO, and the molecular weight is 4492. It has the following primary amino acid sequence:
CHCO-Tyr-Thr-Ser-Leu-Ile-His-Ser-Leu-Ile-Glu-Glu-Ser-Gln-Asn-Gln-Gln-Glu-Lys-Asn-Glu-Gln-Glu-Leu-Leu-Glu-Leu-Asp-Lys-Trp-Ala-Ser-Leu-Trp-Asn-Trp-Phe-NH and the following structural formula:
The drug product, FUZEON (enfuvirtide) for Injection, is a white to off-white, sterile, lyophilized powder. Each single-use vial contains 108 mg of enfuvirtide for the delivery of 90 mg. Prior to subcutaneous administration, the contents of the vial are reconstituted with 1 mL of Sterile Water for Injection to provide the delivery of 1 mL of the solution. Each 1 mL of the reconstituted solution contains approximately 90 mg of enfuvirtide with approximate amounts of the following excipients: 22.55 mg of mannitol, 2.39 mg of sodium carbonate (anhydrous), and sodium hydroxide and hydrochloric acid for pH adjustment as needed. The reconstituted solution has an approximate pH of 9.0.
What does FUZEON look like?
What are the available doses of FUZEON?
Lyophilized powder for injection: 108 mg enfuvirtide per vial
What should I talk to my health care provider before I take FUZEON?
How should I use FUZEON?
FUZEON in combination with other antiretroviral agents is indicated for the treatment of HIV-1 infection in treatment-experienced patients with evidence of HIV-1 replication despite ongoing antiretroviral therapy.
This indication is based on results from two controlled studies of 48 weeks duration. Subjects enrolled were treatment-experienced adults; many had advanced disease. There are no studies of FUZEON in antiretroviral naive subjects.
The recommended dose of FUZEON is 90 mg (1 mL) twice daily injected subcutaneously into the upper arm, anterior thigh or abdomen. Each injection should be given at a site different from the preceding injection site, and only where there is no current injection site reaction from an earlier dose. FUZEON should not be injected near any anatomical areas where large nerves course close to the skin, such as near the elbow, knee, groin or the inferior or medial section of the buttocks, skin abnormalities, including directly over a blood vessel, into moles, scar tissue, bruises, or near the navel, surgical scars, tattoos or burn sites. Additional detailed information regarding the administration of FUZEON is described in the FUZEON
What interacts with FUZEON?
Sorry No Records found
What are the warnings of FUZEON?
Sorry No Records found
What are the precautions of FUZEON?
Sorry No Records found
What are the side effects of FUZEON?
Sorry No records found
What should I look out for while using FUZEON?
FUZEON is contraindicated in patients with known hypersensitivity to FUZEON or any of its components .
What might happen if I take too much FUZEON?
There are no reports of human experience of acute overdose with FUZEON. The highest dose administered to 12 subjects in a clinical trial was 180 mg as a single dose subcutaneously. There is no specific antidote for overdose with FUZEON. Treatment of overdose should consist of general supportive measures.
How should I store and handle FUZEON?
Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Reconstituted solution should be stored in the original vial under refrigeration at 2° to 8°C (36° to 46°F) and used within 24 hours.Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Reconstituted solution should be stored in the original vial under refrigeration at 2° to 8°C (36° to 46°F) and used within 24 hours.Capsules: 0.25 mcg calcitriol in soft gelatin, light orange, oval capsules, imprinted with R25; bottles of 30 (NDC 63304-239-30), and bottles of 100 (63304-239-01).Capsules: 0.5 mcg calcitriol in soft gelatin, dark orange, oblong capsules, imprinted with R50; bottles of 100 (NDC 63304-240-01).Oral Solution: a clear, colorless to pale yellow oral solution containing 1 mcg/mL of calcitriol; each amber glass bottle of 15 mL of oral solution supplied with 20 single-use, graduated oral dispensers (NDC 63304-241-59).Calcitriol Capsules and Oral Solution should be protected from light.Store at 59° to 86°F (15° to 30°C).Capsules: 0.25 mcg calcitriol in soft gelatin, light orange, oval capsules, imprinted with R25; bottles of 30 (NDC 63304-239-30), and bottles of 100 (63304-239-01).Capsules: 0.5 mcg calcitriol in soft gelatin, dark orange, oblong capsules, imprinted with R50; bottles of 100 (NDC 63304-240-01).Oral Solution: a clear, colorless to pale yellow oral solution containing 1 mcg/mL of calcitriol; each amber glass bottle of 15 mL of oral solution supplied with 20 single-use, graduated oral dispensers (NDC 63304-241-59).Calcitriol Capsules and Oral Solution should be protected from light.Store at 59° to 86°F (15° to 30°C).Capsules: 0.25 mcg calcitriol in soft gelatin, light orange, oval capsules, imprinted with R25; bottles of 30 (NDC 63304-239-30), and bottles of 100 (63304-239-01).Capsules: 0.5 mcg calcitriol in soft gelatin, dark orange, oblong capsules, imprinted with R50; bottles of 100 (NDC 63304-240-01).Oral Solution: a clear, colorless to pale yellow oral solution containing 1 mcg/mL of calcitriol; each amber glass bottle of 15 mL of oral solution supplied with 20 single-use, graduated oral dispensers (NDC 63304-241-59).Calcitriol Capsules and Oral Solution should be protected from light.Store at 59° to 86°F (15° to 30°C).Capsules: 0.25 mcg calcitriol in soft gelatin, light orange, oval capsules, imprinted with R25; bottles of 30 (NDC 63304-239-30), and bottles of 100 (63304-239-01).Capsules: 0.5 mcg calcitriol in soft gelatin, dark orange, oblong capsules, imprinted with R50; bottles of 100 (NDC 63304-240-01).Oral Solution: a clear, colorless to pale yellow oral solution containing 1 mcg/mL of calcitriol; each amber glass bottle of 15 mL of oral solution supplied with 20 single-use, graduated oral dispensers (NDC 63304-241-59).Calcitriol Capsules and Oral Solution should be protected from light.Store at 59° to 86°F (15° to 30°C).Capsules: 0.25 mcg calcitriol in soft gelatin, light orange, oval capsules, imprinted with R25; bottles of 30 (NDC 63304-239-30), and bottles of 100 (63304-239-01).Capsules: 0.5 mcg calcitriol in soft gelatin, dark orange, oblong capsules, imprinted with R50; bottles of 100 (NDC 63304-240-01).Oral Solution: a clear, colorless to pale yellow oral solution containing 1 mcg/mL of calcitriol; each amber glass bottle of 15 mL of oral solution supplied with 20 single-use, graduated oral dispensers (NDC 63304-241-59).Calcitriol Capsules and Oral Solution should be protected from light.Store at 59° to 86°F (15° to 30°C).
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Enfuvirtide is an antiviral drug .
Non-Clinical Toxicology
FUZEON is contraindicated in patients with known hypersensitivity to FUZEON or any of its components .Cholestyramine
Cholestyramine has been reported to reduce intestinal absorption of fat-soluble vitamins; as such it may impair intestinal absorption of calcitriol (see and
Phenytoin/Phenobarbital
The coadministration of phenytoin or phenobarbital will not affect plasma concentrations of calcitriol, but may reduce endogenous plasma levels of 25(OH)D by accelerating metabolism. Since blood level of calcitriol will be reduced, higher doses of calcitriol may be necessary if these drugs are administered simultaneously.
Thiazides
Thiazides are known to induce hypercalcemia by the reduction of calcium excretion in urine. Some reports have shown that the concomitant administration of thiazides with calcitriol causes hypercalcemia. Therefore, precaution should be taken when coadministration is necessary.
Digitalis
Calcitriol dosage must be determined with care in patients undergoing treatment with digitalis, as hypercalcemia in such patients may precipitate cardiac arrhythmias (see ).
Ketoconazole
Ketoconazole may inhibit both synthetic and catabolic enzymes of calcitriol. Reductions in serum endogenous calcitriol concentrations have been observed following the administration of 300 mg/day to 1200 mg/day ketoconazole for a week to healthy men. However, in vivo drug interaction studies of ketoconazole with calcitriol have not been investigated.
Corticosteroids
A relationship of functional antagonism exists between vitamin D analogues, which promote calcium absorption, and corticosteroids, which inhibit calcium absorption.
Phosphate-Binding Agents
Since calcitriol also has an effect on phosphate transport in the intestine, kidneys and bones, the dosage of phosphate-binding agents must be adjusted in accordance with the serum phosphate concentration.
Vitamin D
Since calcitriol is the most potent active metabolite of vitamin D, pharmacological doses of vitamin D and its derivatives should be withheld during treatment with calcitriol to avoid possible additive effects and hypercalcemia (see ).
Calcium Supplements
Uncontrolled intake of additional calcium-containing preparations should be avoided (see ).
Magnesium
Magnesium-containing preparations (eg, antacids) may cause hypermagnesemia and should therefore not be taken during therapy with calcitriol by patients on chronic renal dialysis.
The majority of subjects (98%) receiving FUZEON in randomized, controlled, open-label, multicenter clinical trials had at least one local injection site reaction; ISRs occurred throughout treatment with FUZEON. Manifestations may include pain and discomfort, induration, erythema, nodules and cysts, pruritus, and ecchymosis . Reactions are often present at more than one injection site. Patients must be familiar with the FUZEON in order to know how to inject FUZEON appropriately and how to monitor carefully for signs or symptoms of cellulitis or local infection.
The following adverse reactions are discussed in greater detail in other sections:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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