Inotersen Injection

What is this medication?

INOTERSEN (in oh TER sen) treats nerve pain, tingling, or numbness in the hands or feet in people with hereditary transthyretin-mediated amyloidosis (hATTR). It works by reducing the buildup of a protein in your body. This decreases the symptoms of hATTR.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Tegsedi

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Kidney disease
• Low blood counts, such as low white cell, platelet, red cell counts
• An unusual or allergic reaction to inotersen, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

This medication is injection under the skin. You will be taught how to prepare and give it. Take it as directed on the presription label. Keep taking it unless your care team tells you to stop.

It is important that you put your used needles and syringes in a special sharps container. Do not put them in a trash can. If you do not have a sharps container, call your pharmacist or care team to get one.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If your next dose is to be taken in less than 2 days, then do not take the missed dose. Take the next dose at your regular time. Do not take double or extra doses.

What may interact with this medication?

• Adenosine
• Aspirin and aspirin-like medications
• Certain medications for infection, such as acyclovir, adefovir, amphotericin B, bacitracin, cidofovir, foscarnet, ganciclovir, gentamicin, pentamidine, vancomycin
• Certain medications that treat or prevent blood clots, such as warfarin, enoxaparin, dalteparin, apixaban, dabigatran, rivaroxaban
• Cisplatin
• Clopidogrel
• Cyclosporine
• Diuretics
• Medications for pain and inflammation, such as ibuprofen, naproxen, NSAIDs
• Pamidronate
• Prasugrel
• Ticagrelor
• Ticlopidine
• Zoledronic acid

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse.

You should make sure you get enough vitamin A while you are taking this medication. Discuss the foods you eat and the vitamins you take with your care team.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Kidney injury—decrease in the amount of urine, swelling of the ankles, hands, or feet
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Low vitamin A level—change in vision, dry eyes, dry skin, frequent infections
• Stroke—sudden numbness or weakness of the face, arm, or leg, trouble speaking, confusion, trouble walking, loss of balance or coordination, dizziness, severe headache, change in vision
• Unusual bruising or bleeding

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

• Fatigue
• Fever
• Headache
• Nausea
• Pain, redness, or irritation at injection site

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store in a refrigerator or at room temperature between 20 and 25 degrees C (68 and 77 degrees F).

Refrigeration (preferred): Store in the refrigerator. Do not freeze. Keep in original container until you are ready to take it. Get rid of any unused medication after the expiration date.

Room Temperature: This medication may be stored at room temperature for up to 6 weeks. Keep in original container. Protect from light. If it is stored at room temperature, get rid of any unused medication after 6 weeks or after it expires, whichever is first.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, ask your pharmacist or care team how to get rid of this medication safely.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.