INDICATION

RASONQUE is a prescription medicine used to treat adults with a type of pancreatic cancer called pancreatic adenocarcinoma:

• that has spread to other parts of the body, and
• who have received at least 1 prior treatment or who cannot receive a combination of cancer treatments.

It is not known if RASONQUE is safe and effective in children.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about RASONQUE?

RASONQUE can cause serious side effects, including: skin reactions, swelling or sores in the mouth (stomatitis), diarrhea, tears in your stomach or intestines (gastrointestinal perforation), and lung or breathing problems (pneumonitis).

• Skin reactions. Skin reactions may be severe. To help reduce your risk of skin reactions and protect your skin when starting and during treatment with RASONQUE:

  • use a topical steroid cream on your face and chest
  • use a moisturizing cream on your skin
  • limit your time in the sun and use sunscreen (broad spectrum SPF 30 or higher) and other sun protection measures such as clothing and hats if you must be in the sun
  • take any other medicines if prescribed by your healthcare provider

  Tell your healthcare provider right away if you develop any signs or symptoms of skin reactions, including:

  1. rash
  2. itching
  3. red, swollen, and painful skin around your finger or toenails
  4. dry skin
  5. cracked skin

• Swelling or sores in the mouth (stomatitis). Mouth sores may be severe. Your healthcare provider may prescribe a mouthwash or other medicines to treat your mouth reactions. Tell your healthcare provider right away if you develop trouble eating, talking, swallowing, or develop any new or worsening signs or symptoms in your mouth, including:

  • pain
  • redness
  • swelling
  • ulcers or sores

• Diarrhea. Diarrhea may be severe. If you develop diarrhea during treatment with RASONQUE, your healthcare provider may prescribe medicines to treat your diarrhea. Tell your healthcare provider right away if you develop new or worsening diarrhea or if the number of bowel movements you have in a day increases by 6 or more.

• Tears in your stomach or intestines (gastrointestinal perforation). Gastrointestinal perforation may be severe and lead to death. Tell your healthcare provider right away if you develop any of the following signs or symptoms:

  • tenderness or pain in your stomach area (abdomen) that is severe or does not go away
  • nausea, vomiting, or vomiting blood
  • blood in the stool or black stool that looks like tar
  • fever or chills

• Lung or breathing problems (pneumonitis). Lung or breathing problems may be severe and lead to death. Tell your healthcare provider right away if you develop any new or worsening breathing problems, including:

  • cough
  • shortness of breath
  • trouble breathing
  • wheezing

The most common side effects of RASONQUE include:

• rash
• diarrhea
• swelling or sores in the mouth
• nausea
• tiredness or weakness
• vomiting
• stomach (abdominal) pain
• swelling in the arms and legs
• decreased appetite
• bleeding

Certain abnormal blood tests are common during treatment with RASONQUE. Your healthcare provider will monitor you for abnormal blood tests and treat you if needed.

Your healthcare provider may decrease your dose, or temporarily or permanently stop treatment with RASONQUE if you develop certain side effects.

Before taking RASONQUE, tell your healthcare provider about all of your medical conditions, including if you:

• are pregnant or plan to become pregnant. RASONQUE can harm your unborn baby.
  Females who are about to become pregnant:

  • Your healthcare provider will do a pregnancy test before you start treatment with RASONQUE.
  • Use effective birth control (contraception) during treatment with RASONQUE and for 1 week after the last dose.
  • Tell your healthcare provider right away if you become pregnant during treatment with RASONQUE.

  Males with female partners who are able to become pregnant:

  • Use effective contraception during treatment with RASONQUE and for 1 week after the last dose.

• are breastfeeding or plan to breastfeed. It is not known if RASONQUE passes into your breast milk.
  Do not breastfeed during treatment and for 1 week after your last dose of RASONQUE.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. RASONQUE can affect the way other medicines work, and other medicines can affect how RASONQUE works, and may increase your risk of side effects.

These are not all the possible side effects of RASONQUE. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/Safety/MedWatch.

Please see full Prescribing Information, including Medication Guide.