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MYALEPTA is a brand name for Metreleptin, supplied as a powder for solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: MYALEPTA (metreleptin for injection) is indicated as an adjunct to diet as a replacement therapy to treat the complications of leptin deficiency in lipodystrophy (LD) patients: • with confirmed congenital generalised LD (Berardinelli-Seip syndrome) or acquired generalised LD (Lawrence syndrome) in adults and children…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations • Treatment should be initiated and monitored by a healthcare professional experienced in the diagnosis and management of metabolic disorders associated with lipodystrophy. , sulfonylurea) may be necessary in some patients to minimize the risk of hypoglycemia.
, sulfonylurea) when treating with Myalepta (see 7 WARNINGS AND PRECAUTIONS). • Limit the use of Bacteriostatic Water for Injection (BWFI) to patients 3 years of age and older. (see 7 WARNINGS AND PRECAUTIONS). • 7WARNINGS AND PRECAUTIONSWhen discontinuing Myalepta, tapering of the dose over a two- week period is recommended in conjunction with a low fat diet.
During tapering, monitor triglyceride levels and consider initiating or adjusting the dose of lipid-lowering medicinal products as needed. Signs and/or symptoms consistent with pancreatitis should prompt an appropriate clinical evaluation (see 7 WARNINGS AND PRECAUTIONS).
2 Recommended Dose and Dosage Adjustment The recommended daily dose of Myalepta is based on body weight as provided in Table 1. In order to ensure patients and carers understand the correct dose to be injected, the prescriber should prescribe the appropriate dose both in milligrams and the volume in millilitres.
In order to avoid medication errors including overdose, dose calculation and dose adjustment guidelines below should be followed. Actual body weight at initiation of treatment should always be used when calculating the dose. Serious Warnings and Precautions • Anti-metreleptin antibodies with neutralizing activity have been identified in patients treated with Myalepta.
The consequences are not well characterized but could include inhibition of endogenous leptin action and loss of Myalepta efficacy. Worsening metabolic control and/or severe infection have been reported. Test for anti-metreleptin antibodies with neutralizing activity in patients with severe infections or loss of efficacy during Myalepta treatment.
com) for neutralizing antibody testing (see 7 WARNINGS AND PRECAUTIONS and 8 ADVERSE REACTIONS). • T-cell lymphoma has been reported in patients with acquired generalised lipodystrophy, both treated and not treated with Myalepta. Carefully consider the benefits and risks of treatment with Myalepta in patients with significant hematologic abnormalities and/or acquired lipodystrophy (see 7 WARNINGS AND PRECAUTIONS and 8 ADVERSE REACTIONS).
). • T-cell lymphoma has been reported in patients with acquired generalised lipodystrophy, both treated and not treated with Myalepta. Carefully consider the benefits and risks of treatment with Myalepta in patients with significant hematologic abnormalities and/or acquired lipodystrophy (see 7 WARNINGS AND PRECAUTIONS and 8 ADVERSE REACTIONS).
, tolerability issues, excessive weight loss, especially in paediatric patients), the dose may be decreased or increased by the recommended dose adjustment levels to the maximum dose listed in Table 1. The maximum tolerated dose may be less than the maximum daily dose outlined in Table 1, as evidenced by excessive weight loss, even if metabolic response is incomplete.
5% haemoglobin A1c (HbA1c) reduction and/or 25% reduction in insulin requirements; and/or • 15% reduction in triglycerides. If clinical response is not seen after 6 months of treatment the physician should ensure that the patient is compliant with the administration technique, is receiving the correct dose and is adherent to diet.
Myalepta dose increases in adults and children based on incomplete clinical response can be considered after a minimum of 6 months following initiation of treatment. Reductions in HbA1c and triglycerides may not be seen in children as metabolic abnormalities may not be present at the start of treatment.
It is anticipated that most children will require increasing per kg dose, especially as they reach puberty. Increasing abnormalities of triglycerides and HbA1c may be seen which may require a dose increase. Dose adjustments in children without metabolic abnormalities should primarily be made according to weight change.
Dose increases should not be made more frequently than every 4 weeks. Dose decreases based on weight loss may be made weekly. The once daily dose of Myalepta can be increased by increments as shown in Table 1 to a maximum Myalepta (metreleptin) Page 7 of 53 daily dose.
). 2 Geriatrics Clinical trials of Myalepta did not include sufficient numbers of patients aged 65 and older (n=1) to determine whether they respond differently from younger patients. 2 CONTRAINDICATIONS • Myalepta is contraindicated in patients who are hypersensitive to this drug 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. • Myalepta is contraindicated in patients with general obesity not associated with confirmed generalised leptin deficiency or confirmed partial lipodystrophy.
1 Dosing Considerations • Treatment should be initiated and monitored by a healthcare professional experienced in the diagnosis and management of metabolic disorders associated with lipodystrophy. , sulfonylurea) may be necessary in some patients to minimize the risk of hypoglycemia.
, sulfonylurea) when treating with Myalepta (see 7 WARNINGS AND PRECAUTIONS). • Limit the use of Bacteriostatic Water for Injection (BWFI) to patients 3 years of age and older. (see 7 WARNINGS AND PRECAUTIONS). • 7WARNINGS AND PRECAUTIONSWhen discontinuing Myalepta, tapering of the dose over a two- week period is recommended in conjunction with a low fat diet.
During tapering, monitor triglyceride levels and consider initiating or adjusting the dose of lipid-lowering medicinal products as needed. Signs and/or symptoms consistent with pancreatitis should prompt an appropriate clinical evaluation (see 7 WARNINGS AND PRECAUTIONS).
2 Recommended Dose and Dosage Adjustment The recommended daily dose of Myalepta is based on body weight as provided in Table 1. In order to ensure patients and carers understand the correct dose to be injected, the prescriber should prescribe the appropriate dose both in milligrams and the volume in millilitres.
• Myalepta is contraindicated in patients who are hypersensitive to this drug 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.
• Myalepta is contraindicated in patients with general obesity not associated with confirmed generalised leptin deficiency or confirmed partial lipodystrophy. • Myalepta is contraindicated in patients with HIV-related lipodystrophy Myalepta (metreleptin) Page 5 of 53
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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, tolerability issues, excessive weight loss, especially in paediatric patients), the dose may be decreased or increased by the recommended dose adjustment levels to the maximum dose listed in Table 1. The maximum tolerated dose may be less than the maximum daily dose outlined in Table 1, as evidenced by excessive weight loss, even if metabolic response is incomplete.
5% haemoglobin A1c (HbA1c) reduction and/or 25% reduction in insulin requirements; and/or • 15% reduction in triglycerides. If clinical response is not seen after 6 months of treatment the physician should ensure that the patient is compliant with the administration technique, is receiving the correct dose and is adherent to diet.
Myalepta dose increases in adults and children based on incomplete clinical response can be considered after a minimum of 6 months following initiation of treatment. Reductions in HbA1c and triglycerides may not be seen in children as metabolic abnormalities may not be present at the start of treatment.
It is anticipated that most children will require increasing per kg dose, especially as they reach puberty. Increasing abnormalities of triglycerides and HbA1c may be seen which may require a dose increase. Dose adjustments in children without metabolic abnormalities should primarily be made according to weight change.
Dose increases should not be made more frequently than every 4 weeks. Dose decreases based on weight loss may be made weekly. The once daily dose of Myalepta can be increased by increments as shown in Table 1 to a maximum Myalepta (metreleptin) Page 7 of 53 daily dose.
06 mg/kg of Myalepta. 5 mL For females > 40 kg once daily dose Individual patient once daily dose in mg = 5 mg Amount to inject once daily dose = 1 mL Special Populations Pediatrics: The safety and efficacy of Myalepta in children aged 0 to 2 years with generalised LD and children aged 0 to 12 years with partial LD has not been established.
Very limited data are available in children with generalised LD < 6 years of age (n=5; range: 1-4 years). Very limited data are available in children with partial LD <18 years of age (n=5; range: 15-17 […]
06 mg/kg of Myalepta. 5 mL For females > 40 kg once daily dose Individual patient once daily dose in mg = 5 mg Amount to inject once daily dose = 1 mL Special Populations Pediatrics: The safety and efficacy of Myalepta in children aged 0 to 2 years with generalised LD and children aged 0 to 12 years with partial LD has not been established.
Very limited data are available in children with generalised LD < 6 years of age (n=5; range: 1-4 years). Very limited data are available in children with partial LD <18 years of age (n=5; range: 15-17 years). Myalepta lyophilized powder when reconstituted with the diluent BWFI (benzyl alcohol preserved) should not be administered in patients under 3 years of age.
Geriatrics (≥65 years old):
Clinical trials of Myalepta did not include sufficient numbers of patients aged 65 and older (n=1) to determine whether they respond differently from younger patients.
Renal impairment:
Myalepta has not been studied in patients with impaired renal function.
Hepatic impairment:
Myalepta has not been studied in patients with impaired hepatic function. 3 Reconstitution Instruct patients to follow the directions below for reconstitution of the lyophilized powder. com/product- monographs/): a) Remove the vial containing the Myalepta lyophilized powder from the refrigerator and allow the vial to warm to room temperature (20°C to 25°C) prior to reconstitution.
b) Visually inspect the vial containing Myalepta. The cake of lyophilized powder should be intact and white in colour. 6 mL of preservative-free sterile water for injection (SWFI) only. Do not reconstitute with other diluents. 1 mL of preservative-free sterile water for injection (SWFI) only.
Do not reconstitute with other diluents. 8 mg should be used immediately, and any remaining reconstituted solution should be discarded. 2 mL of bacteriostatic water for injection (BWFI). 9% benzyl alcohol as a preservative. 3 mg reconstituted with BWFI should be used within 3 days of reconstitution when stored at 2oC to 8 oC and protected from light.
3 mg vials must be reconstituted with SWFI (see 7 WARNINGS AND PRECAUTIONS). Myalepta which […]
In order to avoid medication errors including overdose, dose calculation and dose adjustment guidelines below should be followed. Actual body weight at initiation of treatment should always be used when calculating the dose. Serious Warnings and Precautions • Anti-metreleptin antibodies with neutralizing activity have been identified in patients treated with Myalepta.
The consequences are not well characterized but could include inhibition of endogenous leptin action and loss of Myalepta efficacy. Worsening metabolic control and/or severe infection have been reported. Test for anti-metreleptin antibodies with neutralizing activity in patients with severe infections or loss of efficacy during Myalepta treatment.
com) for neutralizing antibody testing (see 7 WARNINGS AND PRECAUTIONS and