Consumer medicine information

1. Why am I using INLYTA?

INLYTA contains the active ingredient axitinib. INLYTA is used to treat a certain type of kidney cancer called renal cell carcinoma (RCC). For more information, see Section 1. Why am I using INLYTA? in the full CMI.

2. What should I know before I use INLYTA?

Do not use if you have ever had an allergic reaction to INLYTA or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use INLYTA? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with INLYTA and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use INLYTA?

• Your doctor will tell you which tablets you need to take each day. For kidney cancer, the usual starting dose of INLYTA is one 5 mg tablet taken 2 times a day (for a total of 2 tablets each day).

5. What should I know while using INLYTA?

6. Are there any side effects?

Some common side effects may include diarrhoea; tiredness, loss of appetite; hoarseness, change in your voice; tingling or rash on palms of hands or soles of feet; weight loss; weakness; constipation; sensitive to cold, unintentional weight gain, lack of energy; soreness or burning of the mouth, tongue or throat; stomach ache, indigestion; headache, pain in hands or feet; muscle pain, joint pain; change in sense of taste, rash, dry skin, skin redness, scaly skin, itchy skin; dehydration; nose bleeding; piles, or bleeding from the back passage; hair loss; unusual urine colour; ringing or sound in the ears.
Serious side effects may include headaches, dizziness, blurred vision, nausea and vomiting (high blood pressure); foamy and frothy urine with swelling of abdomen, legs or eyes; passing little or no urine (wee), swelling in ankles or feet, confusion, nausea or vomiting, feeling breathless, tired or weak; swelling of feet or legs, leg pain, cough; chest pain or pressure, pain in your arms, back, neck or jaw; shortness of breath; numbness or weakness on one side of your body, loss of co-ordination; trouble speaking or swallowing; confusion, trouble seeing, seizures or fits; severe stomach pain with vomiting and fever.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

1 Name of Medicine

Axitinib.

2 Qualitative and Quantitative Composition

Inlyta is supplied as red film-coated tablets containing 1 mg, 3 mg, 5 mg, or 7 mg of axitinib.
Excipient(s) with known effect. Lactose monohydrate.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Inlyta 1 mg tablets. Red, film-coated, oval tablets, debossed with "Pfizer" on one side and "1 XNB" on the other.
Inlyta 3 mg tablets. Red, film-coated, round tablets, debossed with "Pfizer" on one side and "3 XNB" on the other.
Inlyta 5 mg tablets. Red, film-coated, triangular tablets, debossed with "Pfizer" on one side and "5 XNB" on the other.
Inlyta 7 mg tablets. Red, film-coated, diamond tablets, debossed with "Pfizer" on one side and "7 XNB" on the other.

4 Clinical Particulars

4.9 Overdose

There is no specific treatment for Inlyta overdose. For information on the management of overdose, contact the Poison Information Centre on 13 11 26 (Australia).
In a controlled clinical study with Inlyta for the treatment of patients with RCC, one patient inadvertently received a dose of 20 mg twice daily for 4 days and experienced dizziness (grade 1).
In a clinical dose finding study with Inlyta, patients who received starting doses of 10 mg twice daily or 20 mg twice daily experienced adverse reactions which included hypertension, seizures associated with hypertension, and fatal haemoptysis.
In cases of suspected overdose, Inlyta should be withheld and supportive care instituted.

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Axitinib was tested using a series of genetic toxicology assays consisting of in vitro bacterial reverse mutation (Ames), human lymphocyte chromosome aberration, and in vivo mouse bone marrow micronucleus assays. Axitinib was not mutagenic in these assays, but induced polyploidy in human lymphocytes in vitro, and was aneugenic in the micronucleus assay at exposure levels approximately 154 times the recommended starting dose in humans.
Carcinogenicity. Carcinogenicity studies have not been performed with axitinib.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Axitinib is a white to light yellow powder with a pKa of 4.8. The solubility of axitinib in aqueous media over the range pH 1.1 to pH 7.8 is in excess of 0.2 microgram/mL. The partition coefficient (n-octanol/ water) is 3.5.
Axitinib has the chemical name N-methyl-2[3((E)-2-pyridin-2-yl-vinyl)- 1H-indazol-6-ylsulfanyl]-benzamide. The molecular formula is C₂₂H₁₈N₄OS and the molecular weight is 386.47 Daltons.
Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSAXITIN.gif CAS number. 319460-85-0.

7 Medicine Schedule (Poisons Standard)

S4 (Prescription Only Medicine).

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/INLYTAST.gif