SPRYCEL® (Spry-sell) (Dasatinib)
- December 30, 2020
- 0
What is SPRYCEL (Dasatinib)?
SPRYCEL is a prescription medicine used to treat adults who have:
- Newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase.
- Ph+ CML who no longer benefit from, or did not tolerate, other treatment, including Gleevec® (imatinib mesylate).
- Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) who no longer benefit from, or did not tolerate, other treatment.
It is not known if SPRYCEL is safe and effective in children younger than 18 years old.
What is the most important information I should know about SPRYCEL?
SPRYCEL can cause serious side effects. These serious side effects include:
- Low Blood Cell Counts: SPRYCEL may cause low red blood cell counts (anemia), low white blood cell counts (neutropenia), and low platelet counts (thrombocytopenia). Your healthcare provider will do blood tests to check your blood cell counts regularly during your treatment with SPRYCEL. Call your healthcare provider right away if you have a fever or any signs of an infection while taking SPRYCEL.
- Bleeding: SPRYCEL may cause severe bleeding that can lead to death. Call your healthcare provider right away if you have:
- Unusual bleeding or bruising of your skin
- Bright red or dark tar-like stools
- A decrease in your level of consciousness, headache, or change in speech.
- Your body may hold too much fluid (fluid retention): In severe cases, fluid may build up in the lining of your lungs, the sac around your heart, or your stomach cavity. Call your healthcare provider right away if you get any of these symptoms during treatment with SPRYCEL:
- Swelling all over your body
- Shortness of breath and cough
- Weight gain
- Heart problems. SPRYCEL may cause an abnormal heart rate, heart problems or a heart attack
- Other common side effects of SPRYCEL therapy include:
- Diarrhea
- Cough
- Fever
- Nausea
- Weakness
- Infections
- Headache
- Skin rash
- Tiredness
- Vomiting
- Muscle pain
How should I take SPRYCEL?
- Take SPRYCEL exactly as prescribed by your healthcare provider.
- Take SPRYCEL with or without food. Try to take SPRYCEL at the same time each day.
- Swallow SPRYCEL tablets whole. Do not break, cut, or crush the tablets.
- Do not change your dose or stop taking SPRYCEL without first talking with your healthcare provider.
- If you miss a dose of SPRYCEL, take your next scheduled dose at its regular time. Do not take two doses at the same time. Call your healthcare provider or pharmacist if you are not sure what to do.
- Your healthcare provider may change your dose of SPRYCEL or tell you to temporarily stop taking SPRYCEL.
Important Safety Information
- Women who are pregnant should not handle crushed or broken SPRYCEL tablets.
- You should not drink grapefruit juice while taking SPRYCEL
- SPRYCEL may harm your unborn baby. Women should not become pregnant while taking SPRYCEL. Talk to your healthcare provider right away if you are pregnant or plan to become pregnant.
- It is not known if SPRYCEL passes into your breast milk or if it can harm your baby. You and your healthcare provider should decide if you will take SPRYCEL or breastfeed. You should not do both.
- SPRYCEL is best absorbed from your stomach into your bloodstream in the presence of stomach acid. You should avoid taking medicines that reduce stomach acid such as: Tagamet® (cimetidine), Protonix® (pantoprazole sodium), Pepcid® (famotidine), Nexium® (esomeprazole), Zantac® (ranitidine), AcipHex® (rabeprazole), Prilosec® (omeprazole), Prevacid® (lansoprazole).
Ask your healthcare provider if you do not know.
What should I tell my healthcare provider before taking SPRYCEL?
- Before you take SPRYCEL, tell your healthcare provider if you:
- Have problems with your immune system
- Have heart problems
-
Have any other medical conditions
- Have liver problems
- Are lactose intolerant
- Are pregnant or planning to become pregnant
-
Are breastfeeding or plan to breastfeed
- Especially tell your healthcare provider if you take medicines that increase the amount of SPRYCEL in your bloodstream such as: Nizoral® (ketoconazole), Nefazodone (serzone, nefadar), Sporanox® (itraconazole), Invirase® (saquinavir), Norvir® (ritonavir), Ketek® (telithromycin), Reyataz® (atazanavir sulfate), E-mycin® (erythromycin), Crixivan® (indinavir), Biaxin® (clarithromycin). Viracept® (nelfinavir),
- If you take medicines that decrease the amount of SPRYCEL in your bloodstream such as: Decadron® (dexamethasone), Rimactane® (rifampin), Dilantin® (phenytoin), Luminal® (phenobarbital), Tegretol® (carbamazepine).
- If you take medicines whose blood levels might change by taking SPRYCEL such as: Sandimmune® (cyclosporine), Rapamune® (sirolimus), Alfenta® (alfentanil), Prograf® (tacrolimus), Fentanyl® (fentanyl), Ergomar® (ergotamine), Orap® (pimozide)
- Medicines that neutralize stomach acid, such as Maalox® (aluminum hydroxide/magnesium hydroxide), Tums® (calcium carbonate), or Rolaids® (calcium carbonate and magnesia) may be taken up to 2 hours before or 2 hours after SPRYCEL
- Since SPRYCEL therapy may cause bleeding, tell your healthcare provider if you are using blood thinner medicine, such as Coumadin® (warfarin sodium) or aspirin.
- Know the medicines you take. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine
General information about SPRYCEL
Medicines are sometimes prescribed for purposes other than those listed in the Patient Information leaflet. Do not use SPRYCEL for a condition for which it is not prescribed. Do not give SPRYCEL to other people even if they have the same symptoms you have. It may harm them
What are the ingredients in SPRYCEL?
Active ingredient: Dasatinib
Inactive ingredient: Lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hydroxypropyl cellulose, and magnesium stearate. The tablet coating consists of hypromellose, titanium dioxide, and polyethylene glycol
