This Product cannot be purchased without a prescription

Masivet UK Cancer Treatment Tablets for Dogs

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What is Masivet?

Masivet contains masitinib, which belongs to a class of medicines having an anti cancer action. It is available as round, orange tablets (50 and 150 mg).

What is Masivet used for?

Masivet is used to treat dogs with mast-cell tumours (a type of cancer). It is used for tumours which are severe in character (grade 2 or 3) and which cannot be removed with surgery. It is only used if the presence of a mutated form of the receptor protein c-kit in the tumours has been confirmed before the start of treatment.
The tablets are given by mouth, once a day. The dose depends on the weight of the dog being treated.. The duration of treatment depends on the dog’s response to treatment.

How does Masivet work?

The active substance in Masivet, masitinib, is a protein-tyrosine kinase inhibitor. This means that it blocks some specific enzymes known astyrosine kinases. These enzymes can be found in some receptors on the surface of cells, including the c-kit receptor. Some types of mast-cell tumour are linked to a mutation that causes excessive action of c-kit and stimulates the mast cells to divide uncontrollably. By blocking these receptors, Masivet might help to control cell division, preventing further development of the tumours with this particular mutation.

How has Masivet been studied?

A number of studies with Masivet were carried out either in laboratory dogs or in animal patients at veterinary practises in Europe and in the USA. The main study compared the effectiveness of Masivet at the recommended dose of 12.5 mg per kilogramme bodyweight once a day with placebo (a dummy treatment). The study included dogs of various breeds and both sexes with mast-cell tumours that had come back after surgery or could not be removed with surgery. The study population included dogs whose tumours contained mutated or normal (‘wild-type’) c-kit receptors.

What is the risk associated with Masivet?

The most common side effects with Masivet are gastrointestinal reactions (diarrhoea andvomiting) and hair loss. These reactions are usually mild to moderate and temporary, lasting for up to four weeks. Dogs under Masivet treatment should be regularly monitored for side effects by the veterinarian (at least monthly). In the case of side effects, the veterinarian might decide to lower the dose of Masivet or to discontinue treatment.
Masivet must not be used in dogs with certain kinds of liver or kidney problems, or anaemia (low red blood cell counts) or neutropenia (low white blood cell counts). It must not be used in dogs less than six months of age or less than 4kg in weight, or bitches that are pregnant or lactating. It should not be used in dogs that may be hypersensitive (allergic) to masitinib or any of the other ingredients. For a full list of all side-effects reported with Masivet, see the Package Leaflet.
Four to six weeks after starting the treatment with Masivet, the veterinarian should check if the treatment is likely to be successful.

What are the precautions for the person who gives the medicine or comes into contact with the animal?

The tablets must be administered whole and should not be divided, broken or ground up. If broken tablets, or the vomit, urine or faeces of a treated dog comes into contact with the skin or eyes, rinse immediately with plenty of water. Children should not have close contact with treated dogs, or their faeces or vomit. If Masivet is taken accidentally, seek medical advice immediately and show the Package Leaflet or the label to the doctor. Do not eat, drink or smoke while treating a dog. For more information, see the Package Leaflet.

Why has Masivet been approved?

The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Masivet exceed the risks for the treatment of non-resectable mast cell tumours(grade 2 or 3) that have a confirmed mutated c-kit tyrosine kinase receptor and recommended that Masivet be given a marketing authorisation. The benefit-risk balance may be found inmodule 6 of this EPAR.

Other information about Masivet

The European Commission granted a marketing authorisation valid throughout the European Union, for Masivet to AB Science S.A. on 17 November 2008. Information on the prescription status of this product may be found on the label/outer package. Because this disease is a life threatening condition and the overall number of dogs affected is expected to be low, the CVMP guidelines on “Minor-Use-Minor-Species (MUMS) data requirements” were applied when assessing the dossier.

This summary was last updated on May 2009.

Datasheet

How to get your prescription medications from PetHealth Direct…easy as 1, 2, 3!

Ask your vet for a written prescription. You can ask us for a blank prescription form if you need one. It might also be helpful for you to fill in the details you know about your pet and your address etc, then take it to your vet to fill in the rest, sign and stamp it.
Go to www.pethealth.direct and search for the name of the medication in the search box, and purchase up to the amount permitted on your prescription.
Send your prescription to us via:

Email to : enquiries@pethealth.direct

or Post to Pet Health Direct Prescriptions West End House, Upper Green, HIgham, Bury St Edmunds, Suffolk, IP28 6PA, UK.

Frequently Asked Questions (FAQs)

Do I need a written prescription from my own vet to buy medicines from Pet Health Direct?

There are many different categories of veterinary medications:

Some medications (categorised as POM-V) require a written prescription from a qualified vet after they have examined your pet;
For others products(categorised as NFA-VPS) we will require details of your pets being treated, which our Suitably Qualified Person can prescribe

In either case, please enter the required details as accurately as possible in order to help expedite your order. To see if a medication requires a prescription, look out for 'Prescription required' on the product page.

Do you accept prescriptions from outside of the UK?

We are not able to send medication to countries outside of the UK under the UK Veterinary Medicines Regulations. A valid prescription is required from a registered vet within the country the medicine is intended to be used.

What is a prescription?

This is the written instruction from your vet explaining which medicine is required, the dose to be given, and details about the patient and veterinarianwho prescribed it. Prescriptions from veterinarians are very similar to those from your GP.

Can I download a template prescription for my vet to fill in?

Yes, please download it from this link. If your vet would rather use their own prescription form, that will be fine too.

Who governs prescriptions and the supply of veterinary medicines for animals?

In the UK, the Veterinary Medicines Directorate (VMD) is responsible for this. They are a British Government department attached to DEFRA. You can see their guidance notes regarding all aspects of Veterinary Medicinal Products by clicking here.

Which medicines require a prescription?

Generally, medicines which can be harmful in some way if used incorrectly require a prescription. Others do not need this legal safeguard on their supply. On the Pethealth.direct website, all medicines will be labelled as “Prescription required” in their product details if this is the case.

Why do some medicines require a prescription?

Some medications are legally classed in this way to safeguard your pet's health and the general public. They may cause harm if used incorrectly. You can buy them from your veterinarian, a pharmacy, or an authorised internet outlet such as ourselves at PetHealth.Direct

How do I get a prescription?

The law changed in 2005 to require veterinarians to allow their clients to buy veterinary medicines from the supplier of their choice. Your vet will be familiar with this procedure, and will provide a signed prescription on request. To save your vet's time, you can print off a blank prescription which you can take to your vet to be completed. You then need to send this to us for review, before we can despatch any “prescription only” medicines (categorised as POM-V).

Will my vet charge me for providing a prescription?

You may find that vets often do charge. You will have to check with the practice as to what his/her prescription fee will be.

Can my vet insist on an extra check-up, or blood test, before providing a written prescription?

Only if they would require that same check-up if they were going to sell you the medicine themselves. They cannot insist on extra check-ups for clients who choose to buy elsewhere. Most vets will provide repeat prescriptions for long-term medications (such as long-term pain relief for arthritis) for 6 months. After that length of time, they are likely to insist or required legally toexamine your animal before any more medicine can be prescribed.This is very similar to what happens when you get medicines form your GP and it is accepted as the correct procedure under current legislation. It will be down to your veterinary practice to decide on the frequency of check-ups.

Do I need a prescription for 'Prescription Diets'?

No. the name Prescription Diet is used to indicate that they are designed to provide for the health of your pet with particular ingredients that may suit them if they have for instance a particularly reactive skin or if they are needing to lose weight. It is important to advise you that these “Prescription Diets may not be suitable for normal, healthy animals, so you should seek advice from your veterinary practice before feeding them to your pets.

Do I need a prescription for every order of medication?

You can ask your vet to write a “repeat prescription”, which allows you to buy the named medicines a specified number of times. Many vets are happy to supply a prescription which will allow you to enoughmedicines for 6 months. So, the stated quantity of tablets for instance might last for one month, but it might be authorised for five repeat purchases. In this way enough medication for 6 months can be purchased using the same prescription. You can then choose to buy them all at once, or ask us to keep the prescription on file and order one month’s worth as you need them.

Can my vet refuse to issue a prescription?

Legally a vet is obliged, on request, to provide a written prescription for a medicine they would otherwise sell to you for your pet.

Can I return prescription medicines if my animal no longer needs them?

We cannot accept returns of any prescription medication, for any reason. This is due to VMD regulations regarding the safe dispensing of medication –that is because if the medication has left our premises we cannot guarantee its condition if it was returned, so,unfortunately, we cannot accept it back. Your vet will be able to safely dispose of the medication if you ask them.

How long does a prescription last for?

Prescriptions are only valid for a total maximum of 6 months (except scheduled medicines – see below) from the date of issue. All medication must be purchased from each written prescription before the 6 months, after this time has passed the prescription will become invalid.

Can I request a prescription from my vet for a particular medicine?

You can make such a request, but it is only vets thatare authorised to decide which prescription-only medicines are to be used in any particular animal. If you find something which you believe would be beneficial, or cheaper than the medicine your vet has prescribed, then most vets will happily consider such a request. Please note that they will still have the final say. Obviously if your vet does not seem to be helpful about anything, you can seek a second opinion from another vet.

What additional restrictions are there for Scheduled Drugs?

Prescriptions for certain medicines don't quite follow the rules shown above. There are only a small handful of these and they will show on our website as a "Scheduled Drug". The differences regarding prescriptions between these medicines and most of the prescription medicines listed on the website are as follows:

The full quantity of medication allowed on the prescription must be purchased within 28 days of the date signed - not 6 months.
The original prescription must be posted to us - we cannot accept faxed, emailed, uploaded, photocopies, etc for legal reasons.
The prescription must be fully completed by a UK qualified vet and they cannot be shipped abroad.
Repeat purchase of scheduled medications cannot be accepted.
The prescription can only be used once, so the total quantity must be ordered in only one time.

These may seem to be an additional inconvenience, but this is UK Law. Unfortunately, we cannot make any exceptions, regardless of the situation.

Where can I find more information about Authorised Medications?

Information about all medicines authorised for use in the UK are available as a "Summary of Product Characteristics" (SPC) on the website of the Veterinary Medicines Directorate. Please use this this link to be taken to that website where you can search their database for the SPC using the brand name of the medicine you are interested in. This is in addition to the product datasheet which can be found under the description of the product on the PetHealth.Direct website.

What to do if your pet experiences an adverse reaction to a medicinal product

No medicine is risk free and all medicines have the potential to cause adverse effects. Some of the adverse effects are known about and these are explained in the SPC of products. Others that may only rarely occur or are specific for certain breeds or groups of animals may only be seen when the products are used more widely. If you suspect that you or your animal has had an adverse reaction to a veterinary medicine, or you think the medicine hasn’t worked as it should have done, report it to the VMD using the form available via the link below:

https://www.vmd.defra.gov.uk/adversereactionreporting/

If you are concerned about any adverse effects yout pet may be suffering it is important to seek the advice of your Veterinary Surgeon

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