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SANDOZ MIGLUSTAT is a brand name for Miglustat, supplied as a capsule. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Sandoz Miglustat (miglustat) is indicated for: the treatment of adult patients with mild to moderate Type 1 Gaucher disease for whom enzyme replacement therapy is not a therapeutic option. slowing the progression of some of the neurological manifestations in adult and pediatric (4-17 years of age) patients with…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Dose selection may need to be adjusted for patients with mild or moderate renal impairment. Use in patients with severe renal impairment is not recommended. Due to teratogenic risk, pregnancy should be ruled out prior to administration (see 16 NON-CLINICAL TOXICOLOGY).
Temporary dose reduction may be necessary in some patients because of diarrhea. The risk of diarrhea may be reduced if Sandoz Miglustat is taken between meals (see 7 WARNINGS AND PRECAUTIONS). The benefit to the patient of treatment with Sandoz Miglustat should be evaluated on a regular basis.
Switching from enzyme replacement therapy to Sandoz Miglustat in Gaucher disease: Switching to Sandoz Miglustat should be considered only for patients who have had their disease well stabilized on enzyme replacement therapy. 2 Recommended Dose and Dosage Adjustment Dosage in type 1 Gaucher Disease Adults The recommended dose for the treatment of patients with Type 1 Gaucher disease is one 100 mg capsule administered orally three times a day at regular intervals.
Temporary dose reduction to 100 mg once or twice a day may be necessary in some patients because of diarrhea or tremor (see 7 WARNINGS AND PRECAUTIONS, Gastrointestinal, Neurological). Pediatrics (under 18 years of age) Health Canada has not authorized this indication for pediatric use.
Dosage in Niemann-Pick Type C Disease Adults and juvenile (12-17 years old) The recommended dose for the treatment of adult and juvenile patients with Niemann -Pick Type C disease is 200 mg three times a day. Pediatrics (4-12 years of age) Patients below 4 years of age were not enrolled in the prospective study of miglustat in Niemann-Pick Type C disease.
47 100 mg once a day Special Populations Geriatrics (≥ 65 years) No data are available to Health Canada; therefore, Health Canada has not authorized an indication for geriatric use. Renal Impairment There is a close relationship between renal function and clearance of miglustat.
Exposure of miglustat is markedly increased in patients with severe renal impairment. 73 m2) Sandoz Miglustat administration should commence at a dose of 100 mg twice per day in patients with Type 1 Gaucher disease and at a maximum dose of 200 mg twice per day with Niemann-Pick Type C disease.
Starting dose should be adjusted for body surface area in pediatric patients (4-12 years of age) with Niemann-Pick Type C disease. 73 m2), Sandoz Miglustat administration should commence at a maximum dose of 100 mg once per day in patients with Type 1 Gaucher disease and at a dose of 100 mg twice per day with Niemann-Pick Type C disease.
1 Adverse Reaction Overview Type 1 Gaucher Disease Sandoz Miglustat Page 13 of 57 The safety of miglustat in patients with Type 1 Gaucher disease has been assessed in the core and extension periods of six open-label monotherapy studies where 132 patients were exposed to miglustat.
Most of the 132 patients with Type 1 Gaucher disease in the combined data set from the clinical studies reported at least one adverse event during their treatment period. These events appeared at the outset of treatment or occurred intermittently during treatment.
The most frequent (≥ 10%) adverse reactions were diarrhea (83%), weight decrease (49%), flatulence (52%), abdominal pain (23%), abdominal pain upper (14%), tremor (29%), headache (14%), fatigue (10%) and nausea (10%). The majority of cases were mild or moderate in severity, and resolved spontaneously, after dose reduction, or upon treatment discontinuat ion.
See 7 WARNINGS AND PRECAUTIONS. 6%) of the 132 patients exposed to miglustat for at least 5 years withdrew from the study due to an adverse event. 5%). With regards to all patients enrolled during the first 6 months of treatment, withdrawals due to adverse events were more common in the 100 mg three times a day miglustat treatment group (11%) than in the 50 mg three times a day miglustat (6%) or the Combination treatment groups (3%).
Twenty-three (29%) patients had an adverse event that resulted in a dose reduction. The most common of these adverse events were diarrhea, weight loss, and tremor. During the first 6 months of treatment, dose reductions due to adverse events were more common in the combination treatment group than in the 100 mg three times a day miglustat (6%) and 50 mg three times a day miglustat (4%) treatment groups.
Niemann-Pick Type C Disease The safety information of miglustat in Niemann-Pick Type C disease has been assessed in a prospective open-label clinical trial and an uncontrolled sub-study where 40 patients were exposed to miglustat. 5% experienced at least one adverse event during their treatment period.
and 16 NON-CLINICAL TOXICOLOGY). 1 Dosing Considerations Dose selection may need to be adjusted for patients with mild or moderate renal impairment. Use in patients with severe renal impairment is not recommended. Due to teratogenic risk, pregnancy should be ruled out prior to administration (see 16 NON-CLINICAL TOXICOLOGY).
Temporary dose reduction may be necessary in some patients because of diarrhea. The risk of diarrhea may be reduced if Sandoz Miglustat is taken between meals (see 7 WARNINGS AND PRECAUTIONS). The benefit to the patient of treatment with Sandoz Miglustat should be evaluated on a regular basis.
Switching from enzyme replacement therapy to Sandoz Miglustat in Gaucher disease: Switching to Sandoz Miglustat should be considered only for patients who have had their disease well stabilized on enzyme replacement therapy. 2 Recommended Dose and Dosage Adjustment Dosage in type 1 Gaucher Disease Adults The recommended dose for the treatment of patients with Type 1 Gaucher disease is one 100 mg capsule administered orally three times a day at regular intervals.
Temporary dose reduction to 100 mg once or twice a day may be necessary in some patients because of diarrhea or tremor (see 7 WARNINGS AND PRECAUTIONS, Gastrointestinal, Neurological). Pediatrics (under 18 years of age) Health Canada has not authorized this indication for pediatric use.
Dosage in Niemann-Pick Type C Disease Adults and juvenile (12-17 years old) The recommended dose for the treatment of adult and juvenile patients with Niemann -Pick Type C disease is 200 mg three times a day. Pediatrics (4-12 years of age) Patients below 4 years of age were not enrolled in the prospective study of miglustat in Niemann-Pick Type C disease.
47 100 mg once a day Special Populations Geriatrics (≥ 65 years) No data are available to Health Canada; therefore, Health Canada has not authorized an indication for geriatric use. Renal Impairment There is a close relationship between renal function and clearance of miglustat.
Sandoz Miglustat is contraindicated in patients who are hypersensitive to miglustat or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
Sandoz Miglustat is contraindicated in women who are or may become pregnant. If Sandoz Miglustat is administered to women of reproductive potential, they should be informed of the potential hazard to the foetus (see 7 WARNINGS AND PRECAUTIONS and 16 NON-CLINICAL TOXICOLOGY).
Sandoz Miglustat Page 6 of 57
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Starting dose should be adjusted for body surface area in pediatric patients (4-12 years of age) with Niemann-Pick Type C disease. 73 m2) is not recommended. In patients with renal impairment continued monitoring and appropriate dosage adjustment is recommended.
Hepatic Impairment Miglustat has not been evaluated in patients with moderate to severe hepatic impairment. No metabolites of miglustat have been detected in animals or in humans either in-vivo or in-vitro. Miglustat is known to be substantially excreted by the kidney.
There is insufficient clinical experience in patients with hepatic impairment to provide dosing recommendations. 3 Reconstitution No reconstitution required. 4 Administration Capsules should be swallowed whole with water. Sandoz Miglustat can be taken with or without food.
The risk of diarrhea may be reduced if Sandoz Miglustat is taken between meals (see 7 WARNINGS AND PRECAUTIONS). 5 Missed Dose If a scheduled dose of Sandoz Miglustat is missed, a double dose should not be taken to make up for the forgotten individual dose.
The patient should take the next dose at the usual scheduled time.
5%), and flatulence (55%). Nine patients withdrew from the study because of an adverse event including two from the pediatric (4-12 years of age) population. 5 months after miglustat discontinuation). In patients with Type 1 Gaucher disease, isolated additional serious adverse drug reactions were reported from ongoing studies and include the following: gastrointestinal polyposis, and cerebellar syndrome.
In patients with Niemann-Pick Type C disease, 11 patients reported a total of 23 serious adverse events. The most frequent serious adverse events were infections and infestations and gastrointestinal disorders. None of the serious adverse events leading to discontinuation was considered related to miglustat treatment.
2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. Type 1 Gaucher Disease Information presented in this section represents findings of 132 patients miglustat-treated patients from the core (0-12 months) and extension (12-54 months) periods of six clinical studies OGT 918-001, OGT 918-003, OGT 918-004, OGT 918-005, OGT 918-011 and OGT 918- 016.
A total of 132 patients were treated with miglustat and were included in the safety population. This included 28 patients from study OGT 918-001 (100 mg three times a day), 18 patients from study OGT 918-003 (50-100 mg three times a day), 34 patients from study OGT 918-004 (100 mg three times a day), 10 patients from study OGT 918-005 (100 mg three times a day) and 42 patients from study OGT 918-011 (100 mg three times a day).
1 years with 81% of the patients exposed for at least 6 months and 37% exposed for at least 2 years. Study OGT 918-011 was an open-label, non comparative 2-year study of 42 patients with Type 1 Gaucher disease who received a minimum of 3 years enzyme replacement therapy and who fulfilled criteria of stable disease for at least 2 years.
Study OGT 918-016 included patients previously enrolled in studies OGT 918-001, -003, and -004. Adverse reactions by MedDRA Primary System Organ Class and Preferred Term with an incidence of >1% of patients treated with miglustat are presented below in Table 1.
Table 1 - Adverse Reactions by Primary System Organ Class and Preferred Term Occurring in Type 1 Gaucher Disease patients with an Incidence of >1% Sandoz Miglustat Page 15 of 57 ADVERSE REACTIONS Primary System Organ Class: Preferred Term Miglustat (N=132) N % Blood and Lymphatic System Disorders Thrombocytopenia 6 5 Ear and Labyrinth Disorders Vertigo 2 2 Eye Disorders Vision Blurred 2 2 Gastrointestinal Disorders Diarrhea Flatulence Abdominal Pain Abdominal Pain Upper Nausea Abdominal Distension Abdominal Discomfort Constipation Vomiting Dyspepsia Gastrointestinal Pain Dry mouth Gastritis 110 68 30 19 13 10 8 7 3 5 4 2 2 83 52 23 14 10 8 6 5 2 4 3 2 2 General Disorders and Administration Site Conditions […]
Exposure of miglustat is markedly increased in patients with severe renal impairment. 73 m2) Sandoz Miglustat administration should commence at a dose of 100 mg twice per day in patients with Type 1 Gaucher disease and at a maximum dose of 200 mg twice per day with Niemann-Pick Type C disease.
Starting dose should be adjusted for body surface area in pediatric patients (4-12 years of age) with Niemann-Pick Type C disease. 73 m2), Sandoz Miglustat administration should commence at a maximum dose of 100 mg once per day in patients with Type 1 Gaucher disease and at a dose of 100 mg twice per day with Niemann-Pick Type C disease.
Starting dose should be adjusted for body surface area in pediatric patients (4-12 years of age) with Niemann-Pick Type C disease. 73 m2) is not recommended. In patients with renal impairment continued monitoring and appropriate dosage adjustment is recommended.
Hepatic Impairment Miglustat has not been evaluated in patients with moderate to severe hepatic impairment. No metabolites of miglustat have been detected in animals or in humans either in-vivo or in-vitro. Miglustat is known to be substantially excreted by the kidney.
There is insufficient clinical experience in patients with hepatic impairment to provide dosing recommendations. 3 Reconstitution No reconstitution required. 4 Administration Capsules should be swallowed whole with water. Sandoz Miglustat can be taken with or without food.
The risk of diarrhea may be reduced if Sandoz Miglustat is taken between meals (see 7 WARNINGS AND PRECAUTIONS). 5 Missed Dose If a scheduled dose of Sandoz Miglustat is missed, a double dose should not be taken to make up for the forgotten individual dose.
The patient should take the next dose at the usual scheduled time. 5 OVERDOSAGE In the clinical development program for miglustat, no patient experienced an overdose of study drug. However, miglustat has been administered at doses of up to 3000 mg/day (approximately 10 times the recommended dose administered to Gaucher patients) for up to six months in Human Immunodeficiency Virus (HIV)-positive patients.
Adverse events observed in the HIV studies included granulocytopenia, dizziness, and paresthesia. Leukopenia and neutropenia have also been observed in a similar group of patients receiving 800 mg/day or above. For management of a suspected drug overdose, contact your regional poison control centre.
6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients Oral Capsule / 100 mg Capsule contents: magnesium stearate, povidone, and sodium starch glycolate.
Capsule shell: gelatin and titanium dioxide Sandoz Miglustat capsules are supplied in hard capsules containing 100 mg of miglustat. Sandoz Miglustat 100 mg are white opaque capsules filled with white to off white granulate. Sandoz Miglustat capsules are supplied in boxes containing 5 blister cards of 18 capsules each (90 capsules/box).
Sandoz Miglustat Page 9 of 57 7 WARNINGS AND PRECAUTIONS Therapy should be directed by physicians knowledgeable in the management of patients with Gaucher disease or Niemann-Pick Type C disease, as appropriate. General Severe Gaucher […]