Ezallor (rosuvastatin)

Ezallor Sprinkle (rosuvastatin) is a prescription medicine used in adults along with diet to:

• lower the level of your “bad” cholesterol (LDL).
• lower the level of fat in your blood (triglycerides).

Pediatric use information for patients 7 to 17 years of age is approved for AstraZeneca's CRESTOR (rosuvastatin calcium) tablets. However, due to AstraZeneca's marketing exclusivity rights, this drug product is not labeled with that pediatric information.

It is not known if Ezallor Sprinkle is safe and effective in people who have Fredrickson Type I and V dyslipidemias.

Ezallor Sprinkle may cause serious side effects, including:

• Muscle pain, tenderness and weakness (myopathy). Muscle problems, including muscle breakdown, can be serious in some people and rarely cause kidney damage that can lead to death. Tell your doctor right away if:
  • you have unexplained muscle pain, tenderness, or weakness, especially if you have a fever or feel more tired than usual, while you take Ezallor Sprinkle.
  • you have muscle problems that do not go away even after your doctor has told you to stop taking Ezallor Sprinkle. Your doctor may do further tests to diagnose the cause of your muscle problems.

Your chances of getting muscle problems are higher if you:

• are taking certain other medicines while you take Ezallor Sprinkle
• are 65 years of age or older
• have thyroid problems (hypothyroidism) that are not controlled
• have kidney problems
• are taking higher doses of Ezallor Sprinkle

Liver problems. Your doctor should do blood tests to check your liver before you start taking Ezallor Sprinkle and if you have symptoms of liver problems while you take Ezallor Sprinkle. Call your doctor right away if you have any of the following symptoms of liver problems:

• feel unusually tired or weak
• loss of appetite
• upper belly pain
• dark urine
• yellowing of your skin or the whites of your eyes

The most common side effects may include: headache, muscle aches and pains, abdominal (stomach) pain, weakness, and nausea.

Additional side effects that have been reported with Ezallor Sprinkle include memory loss and confusion.

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Ezallor Sprinkle. Call your doctor for medical advice about side effects.

You may report side effects to FDA at 1-800-FDA-1088.

• Take Ezallor Sprinkle exactly as your doctor tells you to take it.
• Take Ezallor Sprinkle, by mouth, 1 time each day. Swallow the capsule whole.
• Do not crush or chew Ezallor Sprinkle.
• Ezallor Sprinkle can be taken at any time of day, with or without food.
• If you have trouble swallowing a whole capsule, you can open the capsule and take the contents with soft food (applesauce, or chocolate-or vanilla-flavored pudding).
• Do not change your dose or stop Ezallor Sprinkle without talking to your doctor.
• Your doctor may do blood tests to check your cholesterol levels before and during your treatment with Ezallor Sprinkle. Your doctor may change your dose of Ezallor Sprinkle if needed.
• Your doctor may start you on a cholesterol lowering diet before giving you Ezallor Sprinkle. Stay on this diet when you take Ezallor Sprinkle.
• Wait at least 2 hours after taking Ezallor Sprinkle to take an antacid that contains a combination of aluminum and magnesium hydroxide.
• If you miss a dose of Ezallor Sprinkle, take it as soon as you remember. Do not take 2 doses of Ezallor Sprinkle within 12 hours of each other.
• If you take too much Ezallor Sprinkle or overdose, call your doctor or go to the nearest hospital emergency room right away.

Taking Ezallor Sprinkle with soft food (applesauce, or chocolate-or vanilla-flavored pudding):

For people who have difficulty in swallowing capsules, Ezallor Sprinkle may be given with soft food (applesauce, or chocolate-or vanilla-flavored pudding) as follows:

1. Carefully open the Ezallor Sprinkle capsule.
2. Sprinkle the granules filled in the capsules on 1 teaspoonful of soft food (such as applesauce, or chocolate-or vanilla-flavored pudding.
3. Swallow the granules-soft food mixture within 60 minutes. Do not chew the granules.
4. Do not save the granules-soft food mixture for later use. Throw away any remaining granules-soft food mixture.

Giving Ezallor Sprinkle through a nasogastric tube (NG tube) 16 French or larger, as prescribed by yourdoctor:

For people who have a nasogastric tube in place, Ezallor Sprinkle may be given as follows:

1. Remove the plunger from 60 mL catheter tipped syringe.
2. Carefully open the Ezallor Sprinkle capsule and empty the granules into catheter tipped syringe barrel.
3. Add 40 mL of water to the granules that are inside of the catheter tipped syringe barrel. Do not use other liquids.
4. Replace the plunger and shake the catheter tipped syringe well for 15 seconds.
5. Give the mixture right away through the nasogastric tube into the stomach. Do not save the mixture for later use. Throw away any remaining mixture.
6. After giving the mixture, the nasogastric tube should be flushed with 20 mL of additional water.

Taking Ezallor Sprinkle with certain other medicines may affect each other causing side effects. Ezallor Sprinkle may affect the way other medicines work, and other medicines may affect how Ezallor Sprinkle works.

Especially tell your doctor if you take:

• cyclosporine (a medicine for your immune system)
• gemfibrozil (a fibric acid medicine for lowering cholesterol)
• darolutamide (a medicine for the treatment of prostate cancer)
• regorafenib (a medicine used to treat cancer of the colon and rectum)
• anti-viral medicines including HIV or hepatitis C virus drugs such as:
  • lopinavir, ritonavir, fosamprenavir, tipranavir, atazanavir, simeprevir
  • combination of
    • sofosbuvir/velpatasvir/voxilaprevir
    • dasabuvir/ombitasvir/paritaprevir/ritonavir
    • elbasvir/grazoprevir
    • sofosbuvir/velpatasvir
    • glecaprevir/pibrentasvir and
  • all other combinations with ledipasvir including ledipasvir/sofosbuvir
• certain anti-fungal medicines (such as itraconazole, ketoconazole and fluconazole)
• coumarin anticoagulants (medicines that prevent blood clots, such as warfarin)
• niacin or nicotinic acid
• fibric acid derivatives (such as fenofibrate)
• colchicine (a medicine used to treat gout)

Ask your doctor or pharmacist for a list of these medicines if you are not sure.

Know all of the medicines you take. Keep a list of them to show your doctor and pharmacist when you get new medicine.

Do not take Ezallor Sprinkle if you:

• are pregnant or think you may be pregnant or are planning to become pregnant. Ezallor Sprinkle may harm your unborn baby. If you become pregnant, stop taking Ezallor Sprinkle and call your doctor right away. If you are not planning to become pregnant you should use effective birth control (contraception) while you are taking Ezallor Sprinkle.
• are breastfeeding. Ezallor Sprinkle can pass into your breast milk and may harm your baby.