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Apoquel

Apoquel is an extremely promising new drug aimed at treating the discomfort which is seen in allergic skin disease, especially when that relates to airborne or environmental allergens. Early reports on its use are especially encouraging and sometimes quite dramatic. Vets will prescribe it particularly to treat atopic dermatitis or atopy, which is a common cause if itchiness and discomfort found in dogs which are reacting to house dust and house dust mites, as well as other triggers of allergic skin disease found in the environment. Apoquel can also be used to reduce the itching seen in dogs with other forms of skin allergy, but food elimination trials and treating for parasites (particularly fleas) is strongly recommended. It is also important to make sure that no skin infection is present, so a course of antibiotic might be given too.

Apoquel tablets are given twice daily initially, reducing to once daily after 14 days. Quite often a short course of tablets is all that is needed to control symptoms, but some dogs will go onto once daily dosing for a much longer period. Apoquel tablets suppress a specific part of the immune response in order to work. This is not usually associated with any side effects, but it is possible to see vomiting and diarrhoea, as well as a number of other effects. It is possible that the response to vaccination might be reduced if a vaccine is given while Apoquel tablets are being taken. These factors need to be taken into account, especially if long term use is intended.

  • Product
    Price
     
    QTY
  • 3.6mg Tablets » Priced per tablet
    Out of stock due to a manufacturing issue. We have been advised that there may be issues until early 2015.
    Our price: £1.49
    Currently Unavailable
  • 5.4mg Tablets » Priced per tablet
    Out of stock due to a manufacturing issue. We have been advised that there may be issues until early 2015.
    Our price: £1.49
    Currently Unavailable
  • 16mg Tablets » Priced per tablet
    Out of stock due to a manufacturing issue. We have been advised that there may be issues until early 2015.
    Our price: £2.99
    Currently Unavailable

Description

Presentation

Apoquel tablets contain 3.6, 5.4 or 16 mg oclacitinib (as oclacitinib maleate). Each tablet is marked with “AQ” on one side, with “S”, “M” or “L” on the other side referring to the tablet strengths.

Uses

Indicated for the treatment of pruritus associated with allergic dermatitis and the clinical manifestations of atopic dermatitis in dogs.

Dosage and administration

For oral use.

Dosage and treatment schedule

The recommended initial dose is 0.4 to 0.6 mg oclacitinib/kg bodyweight, administered orally, twice daily for up to 14 days.

For maintenance therapy, the same dose (0.4 to 0.6 mg oclacitinib/kg bodyweight) should then be administered only once a day. The requirement for long-term maintenance therapy should be based on an individual benefit-risk assessment.

Apoquel can be administered with or without food.

The dosing table below shows the number of tablets required. The tablets are breakable along the score line.

Bodyweight (kg) of dog

Strength and number of tablets to be administered.

Initial dose (twice daily) / Maintenance therapy (once daily)

3.6 mg

tablets

5.4 mg

tablets

16 mg

tablets

3.0 – 4.4

½

4.5 – 5.9

½

6.0 – 8.9

1

9.0 – 13.4

1

13.5 – 19.9

½

20.0 – 26.9

2

27.0 – 39.9

1

40.0 – 54.9

55.0 – 80.0

2

Contra-indications, warnings, etc

Do not use in cases of hypersensitivity to the active substance or to any of the excipients.

Do not use in dogs less than 12 months of age or less than 3 kg bodyweight.

Do not use in dogs with evidence of immune suppression, such as hyperadrenocorticism, or with evidence of progressive malignant neoplasia as the active substance has not been evaluated in these cases.

The safety of Apoquel during pregnancy, lactation or in dogs intended for breeding has not been established, so its use is not recommended.

Oclacitinib modulates the immune system and may increase susceptibility to infection and exacerbate neoplastic conditions. Dogs receiving APOQUEL tablets should therefore be monitored periodically with complete blood counts and serum biochemistry when on long-term treatment.

When treating pruritus associated with allergic dermatitis with oclacitinib, investigate and treat any underlying causes (e.g. flea allergic dermatitis, contact dermatitis, food hypersensitivity). Furthermore, in cases of allergic dermatitis and atopic dermatitis, it is recommended to investigate and treat complicating factors, such as bacterial, fungal or parasitic infections/infestations (e.g. flea and mange).

The common adverse reactions seen up to day 16 of the field trials are listed in the following table and compared to placebo:

Adverse reactions observed in atopic dermatitis study up to day 16

Adverse reactions observed in pruritus study up to day 7

APOQUEL

(n=152)

Placebo

(n=147)

APOQUEL

(n=216)

Placebo

(n=220)

Diarrhoea

4.6%

3.4%

2.3%

0.9%

Vomiting

3.9%

4.1%

2.3%

1.8%

Anorexia

2.6%

0%

1.4%

0%

New cutaneous or subcutaneous lumps

2.6%

2.7%

1.0%

0%

Lethargy

2.0%

1.4%

1.8%

1.4%

Polydipsia

0.7%

1.4%

1.4%

0%

After day 16, abnormal clinical signs, in addition to those clinical signs listed above and occurring in greater than 1% of the dogs receiving oclacitinib included pyoderma, non-specified dermal lumps, otitis, histiocytoma, cystitis, yeast skin infections, pododermatitis, lipoma, lymphadenopathy, nausea, increased appetite and aggression. In a laboratory study, the development of papillomas was noted in a number of dogs.

Treatment related clinical pathology changes were restricted to an increase in mean serum cholesterol and a decrease in mean leukocyte count, however, all mean values remained within the laboratory reference range. The decrease in mean leukocyte count observed in oclacitinib-treated dogs was not progressive, and affected all white blood cell counts (neutrophil, eosinophil and monocyte counts) except lymphocyte counts. Neither of these clinical pathology changes appeared clinically significant.

No drug interactions were observed in field studies where oclacitinib was administered concomitantly with veterinary medicinal products such as endo- and ectoparasiticides, antimicrobials and anti-inflammatories.

The impact of oclacitinib administration on vaccination with modified live vaccines, canine parvovirus (CPV), canine distemper virus (CDV) and canine parainfluenza (CPI) and inactivated rabies vaccine (RV), on 16 week old vaccine naïve puppies has been studied. An adequate immune response (serology) to CDV and CPV vaccination was achieved when puppies were administered an overdose of oclacitinib at 1.8 mg/kg bodyweight twice daily for 84 days. However, the findings of this study indicated a reduction in serological response to vaccination with CPI and RV in puppies being treated with oclacitinib compared to untreated controls. The clinical relevance of these observed effects for animals vaccinated while being administered oclacitinib (in accordance with the recommended dosing regimen) has not been established.

Oclacitinib tablets were administered at 1x, 3x and 5x to healthy, one year old Beagle dogs twice daily for 6 weeks followed by once daily for 20 weeks.

Clinical observations that were considered likely to be related to oclacitinib treatment included: alopecia (local), papilloma, dermatitis, erythema, abrasions and scabbing/crusts, interdigital "cysts", and oedema of the paws. Dermatitis lesions were mostly secondary to the development of interdigital furunculosis on one or more paws during the study; the number and frequency of observations increased with increasing dose. Lymphadenopathy of peripheral nodes was noted in all groups and increased in frequency with increasing dose, and was frequently associated with interdigital furunculosis. Papilloma was considered treatment related, but not dose related.

There is no specific antidote and in case of signs of overdose the dog should be treated symptomatically.

User warnings

Wash hands after administration.

In case of accidental ingestion, seek medical advice immediately and show the package leaflet or label to the doctor.

Pharmaceutical precautions

Store below 25°C.

Any remaining half tablet should be placed back in the opened blister and stored (for a maximum of 3 days) in the original cardboard carton.

Do not use after the expiry date which is stated on the blister or carton.

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

Keep out of the sight and reach of children.

For animal treatment only.

Legal category

POM-V

Packaging Quantities

Supplied in packs of 20 or 100 tablets. Each blister strip contains 10 film-coated tablets. Not all pack sizes may be marketed.

Further information

Oclacitinib is a Janus kinase (JAK) inhibitor. It can inhibit the function of a variety of cytokines dependent on JAK enzyme activity. For oclacitinib, the target cytokines are those that are proinflammatory or have a role in allergic responses/pruritis.

Following oral administration in dogs, oclacitinib maleate is rapidly and well absorbed, with a time to peak plasma concentration (tmax) of less than 1 hour. The absolute bioavailability of oclacitinib maleate was 89%.

Total body oclacitinib clearance from plasma was low; 316 ml/h/kg bodyweight (5.3 ml/min/kg bodyweight), and the apparent volume of distribution at steady-state was 942 ml/kg bodyweight. Following intravenous and oral administration, the half-lives were similar at 3.5 and 4.1 hours respectively. Oclacitinib exhibits low protein binding.

Overall the major clearance route is metabolism, with minor contributions from renal and biliary elimination. Inhibition of canine cytochrome P450s is minimal. Therefore, the risk of metabolic drug-drug interactions due to oclacitinib inhibition is very low. No accumulation was observed in the blood of dogs treated for 6 months with oclacitinib.

Marketing authorisation number

EU/2/13/154/001-009.

GTIN (Global Trade Item No)

Apoquel 3.6 mg x 20 tablets:

05414736024769

Apoquel 3.6 mg x 50 tablets:

05414736024776

Apoquel 3.6 mg x 100 tablets:

05414736024783

Apoquel 5.4 mg x 20 tablets:

05414736024790

Apoquel 5.4 mg x 50 tablets:

05414736024806

Apoquel 5.4 mg x 100 tablets:

05414736024813

Apoquel 16 mg x 20 tablets:

05414736024820

Apoquel 16 mg x 50 tablets:

05414736024837

Apoquel 16 mg x 100 tablets:

05414736024844

Need help or advice? Contact us:

  • Freephone: 0800 084 2608
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  • Email: support@viovet.co.uk

All prices include VAT where applicable.

Questions & Answers for Apoquel

Below are some recent questions we've received regarding Apoquel, including answers from our team.

Ask Your Own Question

Why is apoquel 16mg no longer available ? I need it for Antonio

19th Jul 2014
Guadalupe Garza
  • VioVet Customer Since: May 2014
  • From: Texas, United States

Why is Apoquel 16 mg no longer available?

John Cousins
  • Veterinary Surgeon at VioVet

My understanding is this: Apoquel is a complex drug to manufacture. The manufacturer needed to make a large batch in one go, then see how well it sold before setting up the next batch. The initial batch amounted to what the company predicted would be sufficient to supply the whole world for up to 3 years. They badly misjudged how well it was going to sell and in a few months, the three countries where it had been introduced (USA, UK and Germany) had already exhausted the entire global supplies. Obviously the manufacturer soon realised their mistake and quickly scheduled further supplies to be manufactured. However this is a slow process and it will be 2015 before these new supplies are available. In the UK we are expecting to soon have available the stock which had originally been destined for France. This will have French labeling and packaging, but is better than nothing. France and many other countries have still not had their official release of the drug and will now have to wait until 2015 at least it seems. There is inevitably a lot of suspicion and criticism around and all sorts of conspiracy theories. I think the truth is simply that the manufacturer made a very genuine mistake and they are hugely embarrassed and traumatised by it. They are now working flat out to try and get this drug back on the market but they are not magic and cannot conjure it up any quicker. The complexity of the manufacturing process and the checks and controls on the final product are the very reason why this drug is so amazingly safe and effective, so we cannot complain. If they cut corners and churned a whole lot out, the results could easily be very bad. Within the company heads may roll, that is up to them, but we just have to wait for new drug to be made. It is as simple as that.

Apoquel

1st May 2014
serena freese

I can't seem to find this medication in the United States as it is on back order. Is it available through you at this time?

John Cousins
  • Veterinary Surgeon at VioVet

The USA has run out and is waiting for more medication. We have large stocks at the moment and can send you up to 3 month's worth for your own dog if supported by a prescription from your vet.

Cost

1st May 2014
Csnyder

How much are the scripts for the small and med sizes? In dollars. How many can I purchase at a time? Thank!

  • Product Management Team at VioVet

The cost will be charged in Pounds Sterling which will be converted to dollars by your bank. We have large stocks at the moment and can send you up to 3 month's worth for your own dog if supported by a prescription from your vet.

Purchasing in France

26th Apr 2014
Antunes

My vêt gave me a prescription in order to buy apoquel.
My question is: must I send you a prescription in french or do I ask my vet an english prescription?

Thanks a lot for your answer.

John Cousins
  • Veterinary Surgeon at VioVet

You can send the prescription in French. That should not be a problem at all.

Apoquel 16 mg

25th Apr 2014
Pamela Downs

I have an 75 lb English Yellow Lab who is 7 years old. He has been allergy tested and is allergic to EVERYTHING! The ONLY thing that helped him is the Apoquel and his life went from pretty sad to wonderful! I have never seen him so healthy in his entire life! Well, now our vet has run out of the medicine and we can't get it, don't know for how long. We have heard you could fill a prescription for us from another customer. Do I scan the prescription to send to you with credit card payment or what is the process? Also, how long would it take to receive a 30 day supply please? Thank you very much!

John Cousins
  • Veterinary Surgeon at VioVet

It usually takes 5-7 days to get to addresses in the USA, though up to 14 days is possible. You can place your order online, pay by credit card, then upload a scanned copy of your vet's prescription directly to the website, or email it afterwards to prescriptions@viovet.co.uk. If you email it then it is helpful to quote the order number you will be given when you place the order online. We cannot send the meds to you until we have received the order and the prescription, but the prescription can follow after the order has been placed.

Apoquel does seem to be a wonder drug and has out-sold all the manufacturer's predictions in the US it seems. We can still get it in the UK at the moment. Ring 0044 1582 842096 if you have any trouble and we will try to help.

Shipping to the US

24th Apr 2014
Diana Burk

Hello,

I need to find out how to get a copy of the apoquel prescription to you in order to have it filled? I am also wondering what the shipping is to California, USA? How long does it usually take to receive the meds?

Thank you,

Diana

John Cousins
  • Veterinary Surgeon at VioVet

You can email a scanned copy of the prescription to prescriptions@viovet.co.uk

Shipping costs £10 (about 16 US dollars)

We usually dispatch as soon as we have received the order, payment and prescription. Delivery normally takes just a few days.

Purchase from USA

23rd Apr 2014
Tom Gray

Can apoquel be legally purchased in the UK from the USA? With a prescription from a USA vet.

John Cousins
  • Veterinary Surgeon at VioVet

Apoquel can only be legally purchased for use in the UK if it has been prescribed by a UK qualified vet. (They must be a Member of the Royal College of Veterinary Surgeons and be able to display MRCVS after their name on a prescription). We have to make appropriate checks on the authenticity of prescriptions we receive if there is any doubt about this. If we export Apoqule it must have been prescribed by a qualified vet in the country of destination.

Apoquel

22nd Apr 2014
Jerry Conner

I live in the United States and I can't get Apoquel because it is out of stock. What do I need to do to get my dog's prescription filled? I called my vet and they said they couldn't write a prescription for overseas. Let me know.

John Cousins
  • Veterinary Surgeon at VioVet

Differrent States in the USA can have different import regulations which you have to comply with. We are finding that many US vets are happy to write out prescriptions which we can fulfill. Some vets are reluctant to write out prescriptions, perhaps for commercial reasons. Others might be concerned about the authenticity of medication bought over the internet. I can say that our Apoquel is bought through the same veterinary wholesalers in the UK as used by all practicing vets here, so ours is 100% genuine. As for the import regulations, you should check with your own state authorities as to what the rules are. Generally we have been told that up to a 90 day supply of tablets for your own pet is perfectly legal for you to buy, but you must not re-sell any medication. We do need a copy of a written prescription from your own vet. If you have a legal right to import the medication then you could try and persuade your vet to give you the prescription. Apoquel does seem to be an amazingly effective and unique drug, so you should have the chance to give it to your dog. Lots of US vets are providing prescriptions for it. You can then scan and email a copy to us, or just upload it to our website when you place an order. We cannot send any without a prescription I am afraid.

Do you have Apoquel

22nd Apr 2014
Doreen Hyde

I wanted to make sure you have apoquel as the Vets here in the states are not able to get more

John Cousins
  • Veterinary Surgeon at VioVet

We have plentiful supplies of Apoquel at the moment and are indeed selling lots of it. The USA has a specific supply problem which has not affected us (yet). We do not expect to have any difficulties with supply in the foreseeable future.

Is this pill safe for pregnant dogs??

11th Apr 2014
vicki

I'd this pill safe for pregnant dogs

John Cousins
  • Veterinary Surgeon at VioVet

The safety of Apoquel during pregnancy, lactation or in dogs intended for breeding has not been established, so its use is not recommended. Your vet could advise otherwise on the basis of a risk/benefit analysis for your particular dog and its stage of pregnancy, but the general rule is no.

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