AB Science
Masivet 50 mg for dogs 30 film-coated tablets

Treatment of non-resectable dog mast cell tumours in dogs

Prescription required* (Exceptions apply)

Masivet is a light-orange, round shape and film-coated tablet, embossed with “50” or “150” on one side, for the treatment of non-resectable dog mast cell tumours (Grade 2 or 3) with confirmed mutated c-kit tyrosine kinase receptor in dogs.

Each Masivet film-coated tablet contains:

Active substance:

  • Masitinib 50 mg (equivalent to masitinib mesylate 59.6 mg)
  • Masitinib 150 mg (equivalent to masitinib mesylate 178.9 mg)

Excipients:

  • Cellulose, microcrystalline
  • Povidone K30
  • Pig liver powder
  • Crospovidone
  • Magnesium stearate

Tablet coating:

  • Macrogol 3350
  • Polyvinyl alcohol
  • Talc
  • Titanium dioxide (E171)
  • Sunset yellow (E110) aluminium lake.

Masivet:

  • Must not be used in pregnant or lactating bitches.
  • Must not be used in dogs less than 6 months of age or less than 4 kg body weight.
  • Must not be used in dogs suffering from liver impairment, defined as AST or ALT > 3 x Upper Limit of Normal (ULN). Do not use in dogs suffering from renal function impairment, defined as Urinary Protein Creatinine (UPC) ratio > 2 or albumin < 1 x Lower Limit of Normal (LLN).
  • Must not be used in dogs with anaemia (haemoglobin < 10 g/dl).
  • Must not be used in dogs with neutropenia defined as absolute neutrophil count < 2,000 /mm3.
  • Must not be used in case of hypersensitivity to the active substance or to any of the excipients.

Masivet posology:

  • For oral use.
  • The recommended dose is 12.5 mg/kg (with a dose range of 11–14 mg/kg) once daily as presented in the table below.
  • In dogs with a bodyweight of less than 15 kg accurate dosing is not always possible. These dogs may be treated with either 50, 100 or 150 mg, if it is feasible to achieve a target dose of 11–14 mg/kg bw.
  • The tablets must be administered as a whole and should not be divided, broken or ground. If a broken tablet is rejected by the dog after chewing, it should be disposed of. Tablets should always be administered in the same manner, with food.
Dog body-weight in kg Number of tablets per dayMasivet 50 mg Number of tablets per day Masivet 150 mg Dose mg/kg (lower weight) Dose mg/kg (upper weight)
> 15 - 18 1 1 13.7 11.1
> 18 - 22 2 1 13.9 11.4
> 22 - 26 - 2 13.6 11.5
> 26 - 30 1 2 13.5 11.7
> 30 - 34 2 2 13.3 11.8
> 34 - 38 - 3 13.2 11.8
> 38 - 42 1 3 13.2 11.9
> 42 - 46 2 3 13.1 12
> 46 - 50 - 4 13 12
> 50 - 54 2 4 13 12.1
> 54 - 58 2 4 13 12.1
> 58 - 62 - 5 12.9 12.1
> 62 - 66 1 5 12.9 12.1
> 66 - 70 2 5 12.9 12.1
> 70 - 74 6 12.9 12.2
> 74 - 78 1 6 12.8 12.2
> 78 2 6 12.8 -
  • If the tablet is regurgitated or vomited within 10 minutes following administration, treatment should be repeated. If the tablet is regurgitated or vomited later than 10 minutes following administration, treatment should not be repeated.
  • The treatment should be reviewed after 4 to 6 weeks in order to assess the initial response. Duration of treatment depends on the response to treatment. Treatment should be maintained in the case of stable disease, i.e. static, partial or complete tumour response, provided that the product is sufficiently well tolerated. In case of tumour progression, treatment is unlikely to be successful and the treatment should be reviewed.

Dose reduction, treatment interruption and treatment discontinuation:

  • Dogs should be monitored carefully and professional judgement should be used to determine the need for dose reduction in the event of possible significant adverse reactions (see section 4.5). Doses can be reduced to 9 mg/kg bodyweight (range 7.5–10.5 mg/kg) or 6 mg/kg bw (range 4.5–7.5 mg/kg) according to the tables below.
  • During clinical studies, the daily dose was decreased due to adverse events in approximately 16 % of treated dogs and mainly due to an increase in transaminases.
  • 9 mg per kg bodyweight once daily as presented in the table below.
Dog body-weight in kg Number of tablets per dayMasivet 50 mg Number of tablets per day Masivet 150 mg Dose mg/kg (lower weight) Dose mg/kg (upper weight)
> 15 - 19.4 - 1 10 7.7
> 19.4 - 25 1 1 10.3 8
> 25 - 30.6 2 1 10 8.2
> 30.6 - 36.1 - 2 9.8 8.3
> 36.1 - 41.7 1 2 9.7 8.4
> 41.7 - 47.2 2 2 9.6 8.5
> 47.2 - 52.8 1 3 9.5 8.5
> 52.8 - 58.3 1 3 9.5 8.6
> 58.3 - 63.9 2 3 9.4 8.6
> 63.9 - 69.4 - 4 9.4 8.6
> 69.4 - 75 1 4 9.4 8.7
> 75 - 80.6 2 4 9.3 8.7

6 mg per kg bodyweight once daily as presented in the table below.

Dog body-weight in kg Number of tablets per dayMasivet 50 mg Number of tablets per day Masivet 150 mg Dose mg/kg (lower weight) Dose mg/kg (upper weight)
> 15 - 20.8 2 - 6.6 4.8
> 20.8 - 29.2 - 1 7.2 5.1
> 29.2 1 1 6.9 5.3
> 37.5 - 45.8 2 1 6.7 5.5
> 45.8 - 54.2 - 2 6.5 5.5
> 54.2 - 62.5 1 2 6.5 5.6
> 62.5 - 70.8 2 2 6.4 5.6
> 70.8 - 79.2 - 3 6.4 5.7
> 79.2 1 3 6.3 -

Masivet is a light-orange, round shape and film-coated tablet, embossed with “50” or “150” on one side, for the treatment of non-resectable dog mast cell tumours (Grade 2 or 3) with confirmed mutated c-kit tyrosine kinase receptor in dogs.

Each Masivet film-coated tablet contains:

Active substance:

  • Masitinib 50 mg (equivalent to masitinib mesylate 59.6 mg)
  • Masitinib 150 mg (equivalent to masitinib mesylate 178.9 mg)

Excipients:

  • Cellulose, microcrystalline
  • Povidone K30
  • Pig liver powder
  • Crospovidone
  • Magnesium stearate

Tablet coating:

  • Macrogol 3350
  • Polyvinyl alcohol
  • Talc
  • Titanium dioxide (E171)
  • Sunset yellow (E110) aluminium lake.

Masivet:

  • Must not be used in pregnant or lactating bitches.
  • Must not be used in dogs less than 6 months of age or less than 4 kg body weight.
  • Must not be used in dogs suffering from liver impairment, defined as AST or ALT > 3 x Upper Limit of Normal (ULN). Do not use in dogs suffering from renal function impairment, defined as Urinary Protein Creatinine (UPC) ratio > 2 or albumin < 1 x Lower Limit of Normal (LLN).
  • Must not be used in dogs with anaemia (haemoglobin < 10 g/dl).
  • Must not be used in dogs with neutropenia defined as absolute neutrophil count < 2,000 /mm3.
  • Must not be used in case of hypersensitivity to the active substance or to any of the excipients.

Masivet posology:

  • For oral use.
  • The recommended dose is 12.5 mg/kg (with a dose range of 11–14 mg/kg) once daily as presented in the table below.
  • In dogs with a bodyweight of less than 15 kg accurate dosing is not always possible. These dogs may be treated with either 50, 100 or 150 mg, if it is feasible to achieve a target dose of 11–14 mg/kg bw.
  • The tablets must be administered as a whole and should not be divided, broken or ground. If a broken tablet is rejected by the dog after chewing, it should be disposed of. Tablets should always be administered in the same manner, with food.
Dog body-weight in kg Number of tablets per dayMasivet 50 mg Number of tablets per day Masivet 150 mg Dose mg/kg (lower weight) Dose mg/kg (upper weight)
> 15 - 18 1 1 13.7 11.1
> 18 - 22 2 1 13.9 11.4
> 22 - 26 - 2 13.6 11.5
> 26 - 30 1 2 13.5 11.7
> 30 - 34 2 2 13.3 11.8
> 34 - 38 - 3 13.2 11.8
> 38 - 42 1 3 13.2 11.9
> 42 - 46 2 3 13.1 12
> 46 - 50 - 4 13 12
> 50 - 54 2 4 13 12.1
> 54 - 58 2 4 13 12.1
> 58 - 62 - 5 12.9 12.1
> 62 - 66 1 5 12.9 12.1
> 66 - 70 2 5 12.9 12.1
> 70 - 74 6 12.9 12.2
> 74 - 78 1 6 12.8 12.2
> 78 2 6 12.8 -
  • If the tablet is regurgitated or vomited within 10 minutes following administration, treatment should be repeated. If the tablet is regurgitated or vomited later than 10 minutes following administration, treatment should not be repeated.
  • The treatment should be reviewed after 4 to 6 weeks in order to assess the initial response. Duration of treatment depends on the response to treatment. Treatment should be maintained in the case of stable disease, i.e. static, partial or complete tumour response, provided that the product is sufficiently well tolerated. In case of tumour progression, treatment is unlikely to be successful and the treatment should be reviewed.

Dose reduction, treatment interruption and treatment discontinuation:

  • Dogs should be monitored carefully and professional judgement should be used to determine the need for dose reduction in the event of possible significant adverse reactions (see section 4.5). Doses can be reduced to 9 mg/kg bodyweight (range 7.5–10.5 mg/kg) or 6 mg/kg bw (range 4.5–7.5 mg/kg) according to the tables below.
  • During clinical studies, the daily dose was decreased due to adverse events in approximately 16 % of treated dogs and mainly due to an increase in transaminases.
  • 9 mg per kg bodyweight once daily as presented in the table below.
Dog body-weight in kg Number of tablets per dayMasivet 50 mg Number of tablets per day Masivet 150 mg Dose mg/kg (lower weight) Dose mg/kg (upper weight)
> 15 - 19.4 - 1 10 7.7
> 19.4 - 25 1 1 10.3 8
> 25 - 30.6 2 1 10 8.2
> 30.6 - 36.1 - 2 9.8 8.3
> 36.1 - 41.7 1 2 9.7 8.4
> 41.7 - 47.2 2 2 9.6 8.5
> 47.2 - 52.8 1 3 9.5 8.5
> 52.8 - 58.3 1 3 9.5 8.6
> 58.3 - 63.9 2 3 9.4 8.6
> 63.9 - 69.4 - 4 9.4 8.6
> 69.4 - 75 1 4 9.4 8.7
> 75 - 80.6 2 4 9.3 8.7

6 mg per kg bodyweight once daily as presented in the table below.

Dog body-weight in kg Number of tablets per dayMasivet 50 mg Number of tablets per day Masivet 150 mg Dose mg/kg (lower weight) Dose mg/kg (upper weight)
> 15 - 20.8 2 - 6.6 4.8
> 20.8 - 29.2 - 1 7.2 5.1
> 29.2 1 1 6.9 5.3
> 37.5 - 45.8 2 1 6.7 5.5
> 45.8 - 54.2 - 2 6.5 5.5
> 54.2 - 62.5 1 2 6.5 5.6
> 62.5 - 70.8 2 2 6.4 5.6
> 70.8 - 79.2 - 3 6.4 5.7
> 79.2 1 3 6.3 -
94.20
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on Thursday 14 November
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