Zilretta

Generic name: triamcinolone acetonide
Dosage form: extended-release injectable suspension
Drug class: Glucocorticoids

Medically reviewed by  A Ras MD.

What is Zilretta?

Zilretta is a prescription medicine that is used to treat arthritis of the knee.

Description

ZILRETTA (triamcinolone acetonide extended-release injectable suspension) is a microsphere formulation of triamcinolone acetonide, a corticosteroid, to be administered by intra-articular injection.

ZILRETTA is formulated in 75:25 poly(lactic-co-glycolic acid) (PLGA) microspheres with a nominal drug load of 25% (w/w) and is provided as a sterile white to off-white powder. ZILRETTA is prepared with a supplied diluent containing an isotonic, sterile, aqueous solution of sodium chloride (NaCl; 0.9% w/w), sodium carboxymethylcellulose (CMC; 0.5% w/w) and polysorbate-80 (0.1% w/w) to form a 5 mL sterile suspension intended for intra-articular injection.

 

Active Ingredient

The chemical name for triamcinolone acetonide is 9-fluoro-11β,16α,17,21-tetrahydroxypregna-1,4-diene- 3,20-dione cyclic 16,17-acetal with acetone. Its structural formula is:

MW 434.50 with a molecular formula of C 24H 31FO 6

Triamcinolone acetonide occurs as a white to almost white, crystalline powder having not more than a slight odor and is practically insoluble in water and very soluble in alcohol. Each vial of ZILRETTA powder contains 40 mg of triamcinolone acetonide in 160 mg of microspheres, resulting in 32 mg of deliverable triamcinolone acetonide

 Mechanism of Action

Triamcinolone acetonide is a corticosteroid with anti-inflammatory and immunomodulating properties. It binds to and activates the glucocorticoid receptor, leading to activation of anti-inflammatory transcription factors such as lipocortins and inhibition of inflammatory transduction pathways by blocking the release of arachidonic acid and preventing the synthesis of prostaglandins and leukotrienes.

 

Before taking Zilretta, tell your doctor:

• If you are allergic to Zilretta; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have any stomach or bowel problems like diverticulitis, diverticulosis, ulcerative colitis, or ulcers.
• If you have any of these health problems: A fungal infection or malaria infection in the brain.
• If you have a herpes infection of the eye.
• If you have an infection where the shot will be given.

This is not a list of all drugs or health problems that interact with this medicine.

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 Zilretta 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 Zilretta?

• Tell all of your health care providers that you take Zilretta. This includes your doctors, nurses, pharmacists, and dentists.
• Very bad and sometimes deadly allergic reactions have rarely happened. Talk with your doctor.
• If you have high blood sugar (diabetes), you will need to watch your blood sugar closely.
• Tell your doctor if you have signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
• You may have more chance of getting an infection. Wash hands often. Stay away from people with infections, colds, or flu.
• Chickenpox and measles can be very bad or even deadly in some people taking steroid drugs like Zilretta. Avoid being near anyone with chickenpox or measles if you have not had these health problems before. If you have been exposed to chickenpox or measles, talk with your doctor.
• This medicine may lower how much natural steroid is in your body. If you have a fever, an infection, surgery, or you are hurt, talk with your doctor. You may need extra doses of oral steroids. These extra steroids will help your body deal with these stresses. Carry a warning card saying that there may be times when you need extra steroids.
• Talk with your doctor before getting any vaccines. Use of some vaccines with Zilretta may either raise the chance of an infection or make the vaccine not work as well.
• Very bad health problems have happened when drugs like this one have been given into the spine (epidural). These include paralysis, loss of eyesight, stroke, and sometimes death. It is not known if drugs like this one are safe and effective when given into the spine. These drugs are not approved for this use. Talk with the doctor.
• If you are 65 or older, use Zilretta 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 Zilretta 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 Zilretta best taken?

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

• It is given as a shot into the knee.
• You may need to lower how much salt is in your diet and take extra potassium. Talk with your doctor.
• This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take Zilretta.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Have a bone density test as you have been told by your doctor. Talk with your doctor.
• Have your eye pressure checked if you are on Zilretta for a long time. Talk with your doctor.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

What are the side effects of Zilretta 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 infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
• Signs of Cushing’s disease like weight gain in the upper back or belly, moon face, very bad headache, or slow healing.
• Signs of a weak adrenal gland like a very bad upset stomach or throwing up, very bad dizziness or passing out, muscle weakness, feeling very tired, mood changes, not hungry, or weight loss.
• Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
• Signs of low potassium levels like muscle pain or weakness, muscle cramps, or a heartbeat that does not feel normal.
• Shortness of breath, a big weight gain, or swelling in the arms or legs.
• Very bad belly pain.
• Black, tarry, or bloody stools.
• Throwing up blood or throw up that looks like coffee grounds.
• Any unexplained bruising or bleeding.
• Bone pain.
• Joint pain or swelling.
• Feeling tired or weak.
• Redness or white patches in mouth or throat.
• Change in eyesight.
• Mental, mood, or behavior changes that are new or worse.
• Low mood (depression).
• Period (menstrual) changes.
• Seizures.
• Skin changes (pimples, stretch marks, slow healing, hair growth).
• A burning, numbness, or tingling feeling that is not normal.
• Redness or swelling where the shot is given.

What are some other side effects of Zilretta?

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:

• Not able to sleep.

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 Zilretta?

• If you need to store Zilretta at home, talk with your doctor, nurse, or pharmacist about how to store it.

Label

Principal Display Panel – Zilretta Cart 32mg Carton Label

• NDC 70801-003-01 Rx Only
• Zilretta ®
• (triamcinolone acetonide extended-release
  injectable suspension)
• 32 mg per vial
• For intra-articular injection only.
• Single-dose kit. Discard unused portion.
• Must be reconstituted
  with the supplied diluent.
• This carton contains:
• 1 Vial of Zilretta
  microsphere powder
• 1 Vial of diluent (5 mL)
  for Zilretta
• 1 sterile vial adapter
• flexion

 

Principal Display Panel – Zilretta Cart 32mg Professional Carton Label

• NDC 70801-003-02 Rx Only
• Zilretta ®
• (triamcinolone acetonide extended-release
  injectable suspension)
• 32 mg per vial
• For intra-articular injection only.
• Single-dose kit. Discard unused portion.
• Must be reconstituted
  with the supplied diluent.
• PROFESSIONAL SAMPLE
• NOT FOR SALE
  OR REIMBURSEMENT
• This carton contains:
• 1 Vial of Zilretta
  microsphere powder
• 1 Vial of diluent (5 mL)
  for Zilretta
• 1 sterile vial adapter
• flexion

SRC: NLM .