Endari

Generic name: Glutamine Powder (For Sickle Cell Disease)
Drug class: Nutraceutical products

Medically reviewed by  A Ras MD.

What is Endari?

Endari is a prescription medicine that is used to treat sickle cell disease.

Description

Endari (L-glutamine) is an amino acid. L-glutamine is designated chemically as (S)-2-aminoglutaramic acid, L-glutamic acid 5-amide, or (S)-2,5-diamino-5-oxopentanoic acid. The molecular formula is C5H10N2O3 with the molecular weight of 146.15 g/mol and the following structural formula:

Endari is formulated as a white crystalline powder and is packaged as 5 grams in a paper-foil-plastic laminate packet for oral administration.

Before taking Endari, tell your doctor:

• If you are allergic to Endari; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Endari with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Endari?

• Tell all of your health care providers that you take Endari. This includes your doctors, nurses, pharmacists, and dentists.
• Follow the diet plan that your doctor told you about.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• If you have Crohn’s disease, talk with your doctor. Worsening of Crohn’s disease can happen with Endari. Sometimes this may be very bad. Talk with your doctor.
• If you are 65 or older, use Endari with care. You could have more side effects.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Endari while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is Endari best taken?

Use Endari as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Keep taking Endari as you have been told by your doctor or other health care provider, even if you feel well.
• Mix with 8 ounces (240 mL) of liquid like water, milk, or apple juice. Do not mix with hot liquids. You can also mix with 4 to 6 ounces (120 to 180 mL) of food like applesauce or yogurt. This medicine may not dissolve all the way.
• After mixing, take your dose right away. Do not store for future use.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

What are the side effects of Endari that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of a pancreas problem (pancreatitis) like very bad stomach pain, very bad back pain, or very bad upset stomach or throwing up.
• Feeling of needing to have a bowel movement often.
• Rectal irritation.
• Very upset stomach or throwing up.
• Very bad belly pain.
• Throwing up blood or throw up that looks like coffee grounds.
• Black, tarry, or bloody stools.
• Chest pain or pressure.

What are some other side effects of Endari?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Gas.
• Upset stomach or throwing up.
• Dry mouth.
• Constipation.
• Belly pain.
• Headache.
• Cough.
• Pain in arms or legs.
• Back pain.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

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.

How do I store and/or throw out Endari?

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions

Label

PRINCIPAL DISPLAY PANEL – 5 GRAM PACKET CARTON

• NDC: 42457-420-60
• ENDARI™
  (L-glutamine oral powder)
• Contents: 60 Packets (5 grams/packet)
• Directions: Mix the contents of each packet with cold or room temperature beverage or food
  immediately before dosing.
• Administer the prescribed amount orally, twice daily, taking no more than 6 packets per day.
• Package is not child resistant. Keep this and all drugs out of reach of children.
• Store at 20°C to 25°C (68°F to 77°F) away from direct sunlight.
• Rx Only
• LOT XX XXX XX XX
  EXP. MM/YYYY
• Manufactured for Emmaus Medical, Inc.

SRC: NLM .