Registered South Africa · SAHPRA

APOQUEL 16 mg

Oclacitinib Maleate equivalent to Oclacitinib

16/21/07 INN generic

What it does

Oclacitinib is a medication used to treat certain allergic conditions in dogs, such as itching and inflammation.

Commonly used for: itching due to allergies, skin inflammation (dermatitis)

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Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Registration & product details

Registration no.
16/21/07
Registration date
2019/12/11
Expiry date
-
Status
Registered
Active ingredient
Oclacitinib Maleate equivalent to Oclacitinib
Dosage form
-
Strength
-
Pack size
-
Therapeutic class
-
Manufacturer / MAH
-
Applicant / LTR
Zoetis South Africa (Pty) Ltd
Country of origin
-

Source: South African Health Products Regulatory Authority · fetched 2026-04-15 21:26:52 · updated 2026-09-23 04:12:19

Disclaimer: This information is sourced from South African Health Products Regulatory Authority (South Africa). Always consult a qualified healthcare professional before using any medication.

About this medicine

Oclacitinib is a medication used to treat certain allergic conditions in dogs, such as itching and inflammation.

What it treats

  • itching due to allergies
  • skin inflammation (dermatitis)

How it works

Oclacitinib works by blocking specific signals in the body that cause itching and inflammation.

Who it's for

This medication is for dogs that suffer from allergic skin conditions.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: oclacitinib

BNF-referenced

Oclacitinib is an oral Janus kinase (JAK) inhibitor that is primarily used for the treatment of allergic dermatitis in dogs and other inflammatory conditions. It selectively inhibits JAK1, which is involved in the signaling pathways of various cytokines and growth factors, leading to a reduction in inflammatory responses. This medication helps to alleviate symptoms associated with allergic reactions and inflammatory diseases by modulating the immune response.

Indications

  • Allergic dermatitis in dogs
  • Atopic dermatitis
  • Other inflammatory skin conditions

Dosage

Children: Refer to the BNF for Children for specific dosage recommendations for paediatric patients.

Adults: Refer to the BNF for specific dosage recommendations based on the condition being treated.

Mechanism of action

Oclacitinib selectively inhibits Janus kinase 1 (JAK1), interfering with the JAK-STAT signaling pathway that mediates the effects of several pro-inflammatory cytokines. By inhibiting JAK1, oclacitinib reduces the activation of downstream signaling pathways, thereby decreasing the production of inflammatory mediators and the overall inflammatory response.

Pharmacodynamics

The pharmacodynamics of oclacitinib involve its ability to modulate immune responses by blocking the action of specific cytokines implicated in inflammation and immune regulation. This leads to a reduction in clinical signs of allergic dermatitis and other inflammatory conditions. Oclacitinib's selectivity for JAK1 minimizes the effects on other JAK pathways, which may reduce the risk of side effects associated with broader JAK inhibitors.

Pharmacokinetics

Oclacitinib is absorbed rapidly after oral administration, with peak plasma concentrations typically occurring within 1 to 2 hours. It has a half-life of approximately 3.5 hours, allowing for relatively frequent dosing. Oclacitinib undergoes hepatic metabolism, primarily via cytochrome P450 enzymes, and is excreted through both urine and feces. The pharmacokinetics can be influenced by factors such as food, age, and liver function.

Contra-indications

  • Hypersensitivity to oclacitinib or any of its components
  • Infections due to viruses, bacteria, fungi, or parasites
  • Pregnancy and lactation

Adverse effects

  • Vomiting
  • Diarrhoea
  • Anorexia
  • Lethargy
  • Weight loss
  • Increased susceptibility to infections
  • Neoplasia

Interactions

  • Other immunosuppressive agents
  • Live vaccines
  • Cytochrome P450 substrates

Precautions

  • Use with caution in patients with a history of neoplasia
  • Monitor for signs of infection
  • Periodic blood tests may be necessary to monitor blood cell counts

Pregnancy

Oclacitinib is not recommended during pregnancy due to potential risks to the fetus.

Breast-feeding

Oclacitinib is not recommended during breastfeeding due to potential risks to the nursing infant.

Storage

Store at room temperature, away from moisture and heat.

Formulations

  • Tablets
  • Oral suspension
PubChem / pathway

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Molecular reference: oclacitinib

PubChem CID 44631938

Molecular formula: C15H23N5O2S

Source: PubChem (NCBI) · pathways from PathBank, Reactome, WikiPathways & PharmGKB.