Ponvory Starter Pack

Ponvory Starter Pack is used to treat relapsing forms of multiple sclerosis in adults (including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease).

Ponvory Starter Pack may also be used for other reasons that are not mentioned in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Ponvory Starter Pack can slow your heart rate when you start taking it. Before your first dose, your heart function will be checked using an electrocardiograph or ECG (sometimes called an EKG).

Ponvory Starter Pack comes in a 14-day starter pack containing tablets of different colors and strengths. Taking the tablets in order will gradually increase your dose during the first 2 weeks.

You may take Ponvory Starter Pack with or without food.

Swallow the tablet whole and do not crush, chew, or break it.

You may get infections more easily, even serious or fatal infections. You will need frequent medical tests, and your risk of infection could last for 2 weeks after you stop taking Ponvory Starter Pack.

If you get an infection, further doses may be delayed until your infection clears up. If you stop taking Ponvory Starter Pack, you may need to use a starter pack again to gradually increase your dose.

Store at room temperature away from moisture and heat.

Always ask your doctor before you stop taking Ponvory Starter Pack for any reason. Your MS symptoms may return and become worse than before or during treatment with this medicine. Tell your doctor if you have any signs of worsening MS.

Ponvory Starter Pack can slow your heart rate when you begin using it. Inform your doctor if you experience slow heartbeats, chest pain, shortness of breath, or a sensation of your heart skipping beats.

You may be more likely to get infections, including serious or life-threatening ones. Contact your doctor if you have a fever, chills, aches, fatigue, vomiting, neck stiffness, confusion, or increased sensitivity to light. Your risk of infection may continue for 2 weeks after you stop taking Ponvory Starter Pack.

You should not use Ponvory Starter Pack if you are allergic to it, or if you have certain serious heart conditions, especially:

• "AV block" or sick sinus syndrome (unless you have a pacemaker); or
• recent (within the past 6 months) heart failure, heart attack, stroke, "mini-stroke" or TIA, chest pain (unstable angina), or other serious heart problem.

Some heart rhythm medications can cause unwanted or dangerous effects when used with Ponvory Starter Pack. Your doctor may change your treatment plan if you also use amiodarone, disopyramide, dofetilide, dronedarone, ibutilide, procainamide, quinidine, or sotalol.

Before you take Ponvory Starter Pack, tell your doctor if you have never had chickenpox or received a varicella vaccine (Varivax). You may need to receive the vaccine and then wait 1 month before taking this medicine.

Tell your doctor if you have received any vaccine within the past 30 days, or if you are scheduled to receive a vaccine.

Tell your doctor if you have a fever or infection, or if you have ever had:

• a weak immune system (caused by disease or by using certain medicine);
• a very slow heart rate;
• heart rhythm problems, long QT syndrome;
• a heart attack, stroke, or chest pain;
• high blood pressure;
• sleep apnea or other breathing problems;
• diabetes;
• liver disease;
• an eye condition called uveitis; or
• skin cancer including melanoma, or basal or squamous cell carcinoma.

May harm an unborn baby. Use effective birth control while using Ponvory Starter Pack and for at least 1 week after your last dose. Tell your doctor if you become pregnant.

Ask a doctor if it is safe to breastfeed while using this medicine.

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

Ponvory Starter Pack may cause serious side effects. Call your doctor right away if you have:

• slow heartbeats, chest pain, shortness of breath, or feel like your heart is skipping beats;
• a light-headed feeling, like you might faint;
• sudden confusion, severe headache, vision loss, or a seizure;
• changes in vision--blurred vision, increased sensitivity to light, seeing unusual colors in your vision, or having blind spots or shadows in the center of your vision;
• liver problems--nausea, vomiting, upper stomach pain, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes);
• skin changes--darkening, a new sore that does not heal, changes in the size or color of a mole, a growth or bump that looks shiny, pearly, or pink; or
• symptoms of infection--fever, headache, body aches, tiredness, vomiting, neck stiffness, increased sensitivity to light.

Common side effects of Ponvory Starter Pack may include:

• cold symptoms such as stuffy nose, sneezing, sore throat;
• high blood pressure; or
• abnormal liver function tests.

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 the FDA at 1-800-FDA-1088.

If you miss up to 3 doses from the Ponvory Starter Pack in a row: Take 1 tablet as soon as you can, then take 1 tablet daily in the planned order for the rest of the pack.

If you miss a dose after the first 2 weeks: Skip the missed dose and take your next dose at the regular time.

Do not take two doses at one time.

Call your doctor if you miss 4 or more doses in a row. You will need to start over, and your heart function may need to be checked again.

Seek emergency medical help or call the Poison Help line at 1-800-222-1222.

Do not get a vaccine without first consulting your doctor. While you are taking Ponvory Starter Pack, a "live" vaccine may not fully protect you from disease, and you could get an infection.

Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, and varicella (chickenpox).

You should not receive a live vaccine within 1 month before starting Ponvory Starter Pack, while taking it, and for at least 1 to 2 weeks after you stop taking it.

You may have a higher risk of skin cancer while using Ponvory Starter Pack. Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outside.

Ponvory Starter Pack can lead to a serious heart problem. Your risk may be higher if you are also taking certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

Inform your doctor about all your other medicines, especially:

• alemtuzumab;
• rifampin;
• heart or blood pressure medication;
• seizure medicine such as carbamazepine or phenytoin; or other drugs that weaken the immune system (cancer medicine, steroids, medicines to prevent organ transplant rejection).
• This list is not complete. Other drugs may affect Ponvory Starter Pack, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Ponvory Starter Pack can have long-lasting effects on your body, especially on your immune system. For 1 or 2 weeks after your last dose, inform any doctor who treats you that you have used this medicine.