Fostamatinib

Fostamatinib comes as a tablet to take by mouth. It is usually taken with or without food twice daily. Take fostamatinib at around the same time(s) every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take fostamatinib exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Your doctor may need to reduce, interrupt, or discontinue your treatment if you experience certain side effects or depending on your treatment response. If your number of platelets (platelet count) does not increase to a certain level after 12 weeks of treatment, your doctor may have to discontinue your treatment. Talk to your doctor about how you are feeling during your treatment.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Fostamatinib may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

1. diarrhea
2. nausea
3. dizziness
4. rash
5. abdominal pain
6. fatigue

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

1. severe diarrhea
2. headache, confusion, dizziness, chest pain, or shortness of breath
3. pain in the upper right part of the stomach
4. yellowing of the skin or eyes
5. dark colored urine
6. nausea
7. vomiting

Fostamatinib may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Do not remove the desiccant canisters (a small canister that contains a substance that absorbs moisture to keep the medication dry).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to fostamatinib. Your doctor will also check your blood pressure regularly during your treatment with fostamatinib.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• It is used to treat immune thrombocytopenia (ITP).

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Animal studies have revealed evidence of embryotoxicity (e.g., fetal death, post-implantation loss, low fetal weight, structural abnormalities) and maternal toxicity at 0.3 to 10 times the maximum recommended human dose (MRHD). There are no controlled data in human pregnancy. It is not known whether this drug can cause fetal harm or adversely affect reproductive capacity in humans.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D and X are being phased out.

Use is not recommended.

US FDA pregnancy category: Not assigned.

Risk Summary: Based on findings from animal studies and the mechanism of action, this drug can cause fetal harm when administered to a pregnant woman.

Comments:
-Adequate methods of contraception should be encouraged.
-If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.