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APO-RILUZOLE is a brand name for Riluzole, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ....................................................................................... 3 CONTRAINDICATIONS .......................................................................................................... 4 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
General Liver Injury / Monitoring Liver Chemistries APO-RILUZOLE is contraindicated in Patients who have hepatic disease or who have baseline transaminases greater than 3 times the ULN (upper limit of normal) (See CONTRAINDICATIONS).
APO-RILUZOLE should be used with caution in patients with a history of abnormal liver function, with known concomitant liver insufficiency or in patients with elevations in any of serum transaminase (ALT/SGPT; AST/SGOT), bilirubin, or gamma-glutamyl transferase (GGT) levels.
Baseline elevations of several liver function tests (especially including elevated bilirubin) should preclude the use of APO-RILUZOLE (See CONTRAINDICATIONS; DOSAGE AND ADMINISTRATION, Special Populations, Hepatic Insufficiency; ADVERSE REACTIONS, Abnormal Hematologic and Clinical Chemistry Findings).
Liver chemistries should be monitored in all patients on APO-RILUZOLE as the drug can increase serum aminotransferase, even in patients without a prior history of liver abnormality. Serum ALT levels should be measured every month during the first 3 months of treatment, every 3 months during the remainder of the first year, and periodically thereafter (See WARNINGS AND PRECAUTIONS, Monitoring and Laboratory Tests).
There were uncommon instances of jaundice and hepatitis. APO-RILUZOLE should be discontinued if the ALT levels increase to 5 X the ULN. There is no experience with dose reduction or rechallenge in patients who have developed an increase of ALT to 5 X ULN.
Readministration of APO-RILUZOLE to patients in this situation cannot be recommended. In cases of APO-RILUZOLE-induced hepatic injury manifested by elevated liver enzymes, the effect of the hepatic injury on riluzole metabolism is unknown (See ACTION AND CLINICAL PHARMACOLOGY, Special Populations and Conditions, Hepatic Insufficiency).
Findings from Clinical Trials Experience in almost 800 ALS patients indicates that about 50% of riluzole-treated patients will experience at least one ALT/SGPT level above the ULN, about 8% will have elevations >3 X ULN, and about 2% of patients will have elevations >5 X ULN.
A single non-ALS patient with epilepsy treated with concomitant carbamazepine and phenobarbital experienced marked, rapid elevations of liver enzymes with jaundice (ALT 26 X ULN, AST 17 X ULN, and bilirubin 11 X ULN) four months after starting riluzole; these returned to normal 7 weeks after treatment discontinuation.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Riluzole in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Maximum increases in serum ALT usually occurred within 3 months after the start of riluzole therapy and were usually transient when < 5 X ULN. In trials, if ALT levels were < 5 X ULN, treatment continued and ALT levels usually returned to below 2 X ULN within 2 to 6 months.
However, treatment in studies was discontinued if ALT levels exceeded 5 X ULN; in these cases, the levels generally returned to less than 2 X ULN within 2 to 6 months. Carcinogenesis and Mutagenesis See the TOXICOLOGY, Mutagenicity section for the animal data.
Page 6 of 34 Hematologic Patients should be warned to report any febrile illness to their physicians. The report of a febrile illness should prompt treating physicians to check white blood cell counts and to discontinue APO-RILUZOLE in case of neutropenia (See ADVERSE REACTIONS, Abnormal Hematologic and Clinical Findings).
Among approximately 5000 patients given riluzole for ALS, there were three cases of marked neutropenia (absolute neutrophil count less than 500/mm3), all seen within the first 2 months of riluzole treatment. In one case, neutrophil counts rose on continued treatment.
In a second case, counts rose after therapy was stopped. A third case was more complex, with marked anemia as well as neutropenia and the etiology of both is uncertain.
Respiratory, Thoracic and Mediastinal Disorders Interstitial lung disease:
Cases of interstitial lung disease have been reported in patients treated with riluzole, some of them were severe (See ADVERSE REACTIONS). g. bilateral diffuse lung opacities), riluzole should be discontinued immediately. In the majority of the reported cases, symptoms resolved after drug discontinuation and symptomatic treatment.
Hepatic/Biliary/Pancreatic See CONTRAINDICATIONS, WARNINGS and PRECAUTIONS, General, Liver Injury / Monitoring Liver Chemistries and Special Population, Hepatic Insufficiency, ACTION AND CLINICAL PHARMACOLOGY, Special Populations and Conditions, Hepatic Insufficiency; DOSAGE AND ADMINISTRATION, Special Population, Hepatic Insufficiency.
Special Populations Pregnant Women:
There are no adequate and well-controlled studies in pregnant women and riluzole is known to cross the placental barrier in rats. APO-RILUZOLE must not be used in pregnant women (See CONTRAINDICATIONS). In the pregnant rat, the transfer of 14C-riluzole across the placenta to the foetus has been detected.
5 times, respectively, the recommended maximum human daily dose on a mg/m2 basis. Evidence of maternal toxicity was also observed at these doses. 5 times the maximum daily dose on a mg/m2 basis.
Nursing Women:
In rat studies, 14C-riluzole was detected in maternal milk. It is not known whether riluzole is Page 7 of 34 excreted in human breast milk. Because many drugs are excreted in human milk, and because of the potential for serious adverse reactions in nursing infants from riluzole, APO-RILUZOLE must not be used in nursing […]