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Zavesca
Overview
What is Zavesca?
Zavesca (miglustat capsules, 100 mg) is an inhibitor of the enzyme glucosylceramide synthase, which is a glucosyl transferase enzyme responsible for the first step in the synthesis of most glycosphingolipids. Zavesca is an N-alkylated imino sugar, a synthetic analog of D-glucose.
The chemical name for miglustat is 1,5-(butylimino)-1,5-dideoxy-D-glucitol with the chemical formula CHNO and a molecular weight of 219.28.
Miglustat is a white to off-white crystalline solid and has a bitter taste. It is highly soluble in water (>1000 mg/mL as a free base).
Zavesca is supplied in hard gelatin capsules each containing 100 mg miglustat for oral administration. Each Zavesca 100 mg capsule also contains sodium starch glycollate, povidone (K30), and magnesium stearate. Ingredients in the capsule shell include gelatin and titanium dioxide, and the shells are printed with edible ink consisting of black iron oxide and shellac.
What does Zavesca look like?
What are the available doses of Zavesca?
Capsules: 100 mg ()
What should I talk to my health care provider before I take Zavesca?
How should I use Zavesca?
Zavesca is a glucosylceramide synthase inhibitor indicated as monotherapy for treatment of adult patients with mild/moderate type 1 Gaucher disease for whom enzyme replacement therapy is not a therapeutic option ().
Therapy should be directed by physicians who are knowledgeable in the management of Gaucher disease.
The recommended dose for the treatment of adult patients with type 1 Gaucher disease is one 100 mg capsule administered orally three times a day at regular intervals. If a dose is missed, the next Zavesca capsule should be taken at the next scheduled time.
It may be necessary to reduce the dose to one 100 mg capsule once or twice a day in some patients due to adverse reactions, such as tremor or diarrhea.
What interacts with Zavesca?
Sorry No Records found
What are the warnings of Zavesca?
Sorry No Records found
What are the precautions of Zavesca?
Sorry No Records found
What are the side effects of Zavesca?
Sorry No records found
What should I look out for while using Zavesca?
None
What might happen if I take too much Zavesca?
Sorry No Records found
How should I store and handle Zavesca?
Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Protect from light. Zavesca is supplied in hard gelatin capsules containing 100 mg miglustat. Zavesca 100 mg capsules are white opaque with "OGT 918" printed in black on the cap and "100" printed in black on the body.Zavesca 100 mg capsules are packed in blister cards. Six blister cards of 15 capsules are supplied in each carton.NDC 66215-201-90: carton containing 90 capsules.NDC 66215-201-15: blister card containing 15 capsulesZavesca is supplied in hard gelatin capsules containing 100 mg miglustat. Zavesca 100 mg capsules are white opaque with "OGT 918" printed in black on the cap and "100" printed in black on the body.Zavesca 100 mg capsules are packed in blister cards. Six blister cards of 15 capsules are supplied in each carton.NDC 66215-201-90: carton containing 90 capsules.NDC 66215-201-15: blister card containing 15 capsulesZavesca is supplied in hard gelatin capsules containing 100 mg miglustat. Zavesca 100 mg capsules are white opaque with "OGT 918" printed in black on the cap and "100" printed in black on the body.Zavesca 100 mg capsules are packed in blister cards. Six blister cards of 15 capsules are supplied in each carton.NDC 66215-201-90: carton containing 90 capsules.NDC 66215-201-15: blister card containing 15 capsules
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Type 1 Gaucher disease is caused by a functional deficiency of glucocerebrosidase, the enzyme that mediates the degradation of the glycosphingolipid glucosylceramide.
Miglustat functions as a competitive and reversible inhibitor of the enzyme glucosylceramide synthase, the initial enzyme in a series of reactions which results in the synthesis of most glycosphingolipids.
Zavesca helps reduce the rate of glycosphingolipid biosynthesis so that the amount of glycosphingolipid substrate is reduced to a level which allows the residual activity of the deficient glucocerebrosidase enzyme to be more effective (substrate reduction therapy). and studies have shown that miglustat can reduce the synthesis of glucosylceramide-based glycosphingolipids.
Non-Clinical Toxicology
NoneInhibitors of CYP3A4 and CYP2D6
The concomitant use of PRIMLEV™ and CYP3A4 inhibitors, such as macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g., ketoconazole), and protease inhibitors (e.g., ritonavir), can increase the plasma concentration of oxycodone, resulting in increased or prolonged opioid effects. These effects could be more pronounced with concomitant use of PRIMLEV™ and CYP3A4 and CYP2D6 inhibitors, particularly when an inhibitor is added after a stable dose of PRIMLEV™ is achieved [see ].
After stopping a CYP3A4 inhibitor, as the effects of the inhibitor decline, the oxycodone plasma concentration will decrease [see ], resulting in decreased opioid efficacy or a withdrawal syndrome in patients who had developed physical dependence to PRIMLEV™.
If concomitant use is necessary, consider dosage reduction of PRIMLEV™ until stable drug effects are achieved. Monitor patients for respiratory depression and sedation at frequent intervals. If a CYP3A4 inhibitor is discontinued, consider increasing the PRIMLEV™ dosage until stable drug effects are achieved. Monitor for signs of opioid withdrawal.
Inducers of CYP3A4
The concomitant use of PRIMLEV™ and CYP3A4 inducers, such as rifampin, carbamazepine, and phenytoin, can decrease the plasma concentration of oxycodone [see ], resulting in decreased efficacy or onset of a withdrawal syndrome in patients who have developed physical dependence to PRIMLEV™ [see ].
After stopping a CYP3A4 inducer, as the effects of the inducer decline, the oxycodone plasma concentration will increase [see ], which could increase or prolong both the therapeutic effects and adverse reactions, and may cause serious respiratory depression.
If concomitant use is necessary, consider increasing the PRIMLEV™ dosage until stable drug effects are achieved. Monitor for signs of opioid withdrawal. If a CYP3A4 inducer is discontinued, consider PRIMLEV™ dosage reduction and monitor for signs of respiratory depression.
Benzodiazepines and Other CNS Depressants
Due to additive pharmacologic effect, the concomitant use of benzodiazepines and other CNS depressants such as benzodiazepines and other sedative hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, and other opioids, including alcohol, can increase the risk of hypotension, respiratory depression, profound sedation, coma, and death.
Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients closely for signs of respiratory depression and sedation [see ].
Serotonergic Drugs
The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system, such as selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), tryptans, 5-HT3 receptor antagonists, drugs that affect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), and monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue), has resulted in serotonin syndrome [see ].
If concomitant use is warranted, carefully observe the patient, particularly during treatment initiation and dose adjustment. Discontinue PRIMLEV™ if serotonin syndrome is suspected.
Monoamine Oxidase Inhibitors (MAOIs)
The concomitant use of opioids and MAOIs, such as phenelzine, tranylcypromine, linezolid, may manifest as serotonin syndrome or opioid toxicity (e.g., respiratory depression, coma) [see ].
The use of PRIMLEV™ is not recommended for patients taking MAOIs or within 14 days of stopping such treatment.
If urgent use of an opioid is necessary, use test doses and frequent titration of small doses to treat pain while closely monitoring blood pressure and signs and symptoms of CNS and respiratory depression.
Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics
The concomitant use of opioids with other opioid analgesics, such as butorphanol, nalbuphine, pentazocine, may reduce the analgesic effect of PRIMLEV™ and/or precipitate withdrawal symptoms.
Advise patient to avoid concomitant use of these drugs.
Muscle Relaxants
PRIMLEV™ may enhance the neuromuscular-blocking action of skeletal muscle relaxants and produce an increase in the degree of respiratory depression.
If concomitant use is warranted, monitor patients for signs of respiratory depression that may be greater than otherwise expected and decrease the dosage of PRIMLEV™ and/or the muscle relaxant as necessary.
Diuretics
Opioids can reduce the efficacy of diuretics by inducing the release of antidiuretic hormone.
If concomitant use is warranted, monitor patients for signs of diminished diuresis and/or effects on blood pressure and increase the dosage of the diuretic as needed.
Anticholinergic Drugs
The concomitant use of anticholinergic drugs may increase risk of urinary retention and/or severe constipation, which may lead to paralytic ileus.
If concomitant use is warranted, monitor patients for signs of urinary retention or reduced gastric motility when PRIMLEV™ is used concomitantly with anticholinergic drugs.
Alcohol, ethyl
Hepatotoxicity has occurred in chronic alcoholics following various dose levels (moderate to excessive) of acetaminophen.
Oral Contraceptives
Increase in glucuronidation resulting in increased plasma clearance and a decreased half-life of acetaminophen.
Charcoal (activated)
Reduces acetaminophen absorption when administered as soon as possible after overdose.
Beta Blockers (Propranolol)
Propranolol appears to inhibit the enzyme systems responsible for the glucuronidation and oxidation of acetaminophen. Therefore, the pharmacologic effects of acetaminophen may be increased.
Loop Diuretics
The effects of the loop diuretic may be decreased because acetaminophen may decrease renal prostaglandin excretion and decrease plasma renin activity.
Lamotrigine
Serum lamotrigine concentrations may be reduced, producing a decrease in therapeutic effects.
Probenecid
Probenecid may increase the therapeutic effectiveness of acetaminophen slightly.
Zidovudine
The pharmacologic effects of zidovudine may be decreased because of enhanced non-hepatic or renal clearance of zidovudine.
Therapy should be directed by physicians knowledgeable in the management of patients with Gaucher disease.
The following serious adverse reactions are described below and elsewhere in the labeling:
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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