Pregnancy & Lactation: Risk data not available
What is Tofersen?
Tofersen is used in adults to treat certain types of amyotrophic lateral sclerosis (ALS).
Your doctor will make sure you have the correct type to be treated with tofersen.
Tofersen may also be used for purposes not listed in this medication guide.
Warnings
Tell your doctor about all your medical conditions or allergies before receiving tofersen.
It is not known if tofersen will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.
Ask a doctor if it is safe to breastfeed while receiving this medicine.
How should I use Tofersen
Use Tofersen (Intrathecal) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.
Your doctor will perform tests to make sure tofersen is the right treatment for you.
Tofersen is injected into the fluid that surrounds the spinal cord. A healthcare provider will give you this injection.
Tofersen is given initially as 3 injections every 14 days, followed by maintenance injections every 28 days.
You may be given a sedative to help you relax during the injection.
After receiving an injection, you will be watched closely to make sure you do not have serious side effects.
You will need frequent medical tests.
Call your doctor for instructions if you miss an appointment for your tofersen injection.
Tofersen side effects
Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.
Some side effects may occur during the injection. Tell your medical caregiver if you feel dizzy, nauseated, light-headed, itchy, sweaty, or have a headache, chest tightness, back pain, trouble breathing, or swelling in your face.
Call your doctor at once if you have:
- severe muscle pain, cramps;
- signs of nerve pain--numbness, weakness, tingling, burning pain;
- signs of meningitis--fever, headache, neck stiffness, increased sensitivity to light, nausea, vomiting, confusion, drowsiness;
- signs of an eye condition called papilledema--blurry vision, swelling, vision changes ; or
- increased pressure inside the skull--severe headaches, ringing in your ears, dizziness, nausea, vision problems, pain behind your eyes.
Your treatments may be delayed or permanently discontinued if you have certain side effects.
Common side effects may include:
- muscle or joint pain, muscle stiffness;
- feeling very tired;
- nerve or back pain;
- pain in your hands or feet; or
- increased white blood cells and protein in fluid around spine.
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.
What other drugs will affect Tofersen?
Follow your doctor's instructions about any restrictions on food, beverages, or activity.