Zilretta Injection

Zilretta is an extended-release corticosteroid injection used to manage osteoarthritis knee pain.

Zilretta is for injection directly into the knee and and should not be administered by any other injection method.

Zilretta injection is not suitable for use in small joints, such as the hand.

The risks and benefits of repeat injections have not been demonstrated.

Zilretta injection is administered by a health professional as a single extended-release injection of triamcinolone acetonide directly into the knee joint.

Triamcinolone can weaken (suppress) your immune system, and you may get an infection more easily. Call your doctor if you have unusual bruising or bleeding, or signs of infection (fever, weakness, cold or flu symptoms, skin sores, diarrhea, frequent or recurring illness).

Your doctor may instruct you to limit your salt intake while you are receiving Zilretta injection. You may also need to take potassium supplements. Follow all instructions.

Triamcinolone can affect the results of certain medical tests. Tell any doctor who treats you that you are using Zilretta.

You may not be able to receive Zilretta if you have a fungal infection, or a condition called idiopathic thrombocytopenic purpura (ITP).

You should not be treated with Zilretta if you are allergic to triamcinolone.

You may not be able to receive Zilretta injection if you have a fungal infection, or a condition called idiopathic thrombocytopenic purpura (ITP).

Tell your doctor if you have ever had:

• an active or chronic infection, including tuberculosis;
• idiopathic thrombocytopenic purpura (ITP);
• high blood pressure, heart problems;
• cataracts, glaucoma, or herpes infection of the eyes;
• a parasite infection that causes diarrhea (such as threadworms);
• a nerve-muscle disorder, such as myasthenia gravis;
• a stomach ulcer, diverticulitis, ulcerative colitis;
• a colostomy or ileostomy, or stomach surgery;
• low bone mineral density; or
• a problem with your thyroid or adrenal gland.

Tell your doctor if you are pregnant or breastfeeding.

Get emergency medical help if you have signs of an allergic reaction to Zilretta: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Zilretta may cause serious side effects. Call your doctor at once if you have:

• (after injection into a joint space) increased pain or swelling, joint stiffness, fever, and general ill feeling;
• blurred vision, tunnel vision, eye pain, or seeing halos around lights;
• unusual changes in mood or behavior;
• swelling, rapid weight gain, feeling short of breath;
• stomach cramps, vomiting, diarrhea, bloody or tarry stools, rectal irritation;
• sudden numbness or weakness (especially on one side of the body);
• a seizure (convulsions);
• severe headache, blurred vision, pounding in your neck or ears;
• increased pressure inside the skull - severe headaches, ringing in your ears, dizziness, nausea, vision problems, pain behind your eyes; or
• signs of low adrenal gland hormones - flu-like symptoms, headache, depression, weakness, tiredness, diarrhea, vomiting, stomach pain, craving salty foods, and feeling light-headed.

Certain side effects may be more likely with long-term use or repeated doses of Zilretta injection.

Steroids can affect growth in children. Tell your doctor if your child is not growing at a normal rate while using this medicine.

Common Zilretta side effects may include:

• skin changes (acne, dryness, redness, bruising, discoloration);
• increased hair growth, or thinning hair;
• nausea, bloating, appetite changes;
• stomach or side pain;
• cough, runny or stuffy nose;
• headache, sleep problems (insomnia);
• a wound that is slow to heal;
• sweating more than usual; or
• changes in your menstrual periods.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Usual Adult Dose of Zilretta for Osteoarthritis: Extended-release: 32 mg/5 mL: For Osteoarthritic Knee Pain only: 32 mg as a single intra-articular injection The safety and efficacy of repeat administration has not been evaluated Comments: If an excessive amount of synovial fluid is present in the joint, aspirate some (not all) to provide pain relief and prevent undue dilution of the steroid. Zilretta is not suitable for use in small joints, such as the hand, it is only indicated for osteoarthritis of the knee.

Call your doctor for instructions if you miss an appointment for a scheduled Zilretta injection.

As Zilretta is used as a single dose, you will not be on a regular dosing schedule.

Since Zilretta is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

Using too much Zilretta is not likely to cause serious problems. However, long term use of high doses can lead to thinning skin, easy bruising, changes in body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.

After injection of Zilretta into the knee joint, avoid overusing that joint through strenuous activity or high-impact sports. You could cause damage to the joint.

Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chickenpox or measles. These conditions can be serious or even fatal in people who are using triamcinolone.

Do not receive a "live" vaccine or a toxoid vaccine while using Zilretta, or you could develop a serious infection. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine. Toxoid vaccines include diphtheria-tetanus toxoid (DT or Td).

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Tell your doctor about all your current medicines. Many drugs can interact with triamcinolone, especially:

• an antibiotic or antifungal medication;
• birth control pills or hormone replacement therapy;
• a blood thinner (warfarin, Coumadin, and others);
• a diuretic or "water pill";
• insulin or oral diabetes medicine;
• medicine to treat tuberculosis;
• a nonsteroidal anti-inflammatory drug or NSAID (aspirin, ibuprofen, naproxen, diclofenac, indomethacin, Advil, Aleve, Celebrex, and many others); or
• seizure medication.

This list is not complete and many other drugs may affect Zilretta. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Flexion Therapeutics, Inc, 10 Mall Rd, Suite 301, Burlington, MA 01803, USA.