Rociletinib

Rociletinib is used to treat non-small cell lung cancer (NSCLC).

Rociletinib has been discontinued.

Dosages of Rociletinib:

• Investigational drug; clinical trials suspended May 2016; based on available data, the FDA advisory committee voted not to approve the drug in April 2016

Dosage Considerations – Should be Given as Follows:

Dosage Considerations – Should be Given as Follows:

Non-small Cell Lung Cancer (NSCLC)

• Investigational drug; clinical trials suspended May 2016; based on available data, the FDA advisory committee voted not to approve the drug in April 2016
• Epidermal growth factor receptor (EGFR) inhibitor for the treatment of patients with mutant EGFR NSCLC who have been previously treated with an EGFR-targeted therapy and have the EGFR T790M mutation

Side effects of Rociletinib include:

• There is no information available on the side effects of rociletinib. Rociletinib was an investigational drug. Clinical trials were suspended in May 2016. Based on available data, the FDA advisory committee voted not to approve rociletinib in April 2016.

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

• There is no information available on severe, serious, moderate, or mild interactions of rociletinib with other drugs. Rociletinib was an investigational drug. Clinical trials were suspended in May 2016. Based on available data, the FDA advisory committee voted not to approve rociletinib in April 2016.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

Warnings

This medication contains rociletinib. Do not take rociletinib if you are allergic to rociletinib or any ingredients contained in this drug.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Contraindications

• No information is available.

Effects of Drug Abuse

• No information is available.

Short-Term Effects

• See "What Are Side Effects Associated with Using Rociletinib?"

Long-Term Effects

• See "What Are Side Effects Associated with Using Rociletinib?"

Cautions

• No information is available.

Pregnancy and Lactation

There is no information available on the use of rociletinib during pregnancy or while breastfeeding. Rociletinib was an investigational drug. Clinical trials were suspended in May 2016. Based on available data, the FDA advisory committee voted not to approve rociletinib in April 2016.