lonafarnib

What is the most important information I should know about lonafarnib?

Tell your doctor about all your current medicines and any you start or stop using. Many drugs can interact, and some drugs should not be used together.

What is lonafarnib?

Lonafarnib is for use in people with certain rare genetic conditions that cause premature and rapid aging. Lonafarnib is for use in adults and children at least 12 months old whose bodies have reached a certain size (a body surface area of 0.39 square meters).

Lonafarnib is used to lower the risk of death in people with Hutchinson-Gilford Progeria Syndrome (HGPS).

Lonafarnib is also used to treat certain types of Progeroid Laminopathies that are "processing-deficient."

This medicine is not for use in people with non-HGPS Progeroid Syndromes or with Progeroid Laminopathies that are "processing-proficient."

Lonafarnib may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking lonafarnib?

Many drugs can interact and cause dangerous effects. Some drugs should not be used together with lonafarnib. Your doctor may change your treatment plan if you also use:

• midazolam;
• St. John's wort;
• phenobarbital or other barbiturate medicine;
• an antibiotic or antifungal medicine;
• antiviral medicine to treat HIV or hepatitis C;
• cancer medicine;
• cholesterol medicine (atorvastatin, lovastatin, or simvastatin);
• heart or blood pressure medicine;
• seizure medicine; or
• steroid medicine.

You may need to stop using lonafarnib for 10 to 14 days before and 2 days after using certain other medicines. Do not stop taking lonafarnib without your doctor's advice.

Tell your doctor if you have ever had:

• kidney disease; or
• eye problems.

This medicine may affect fertility (ability to have children) in both men and women. However, women should still use birth control to prevent pregnancy because lonafarnib can harm an unborn baby.

How should I take lonafarnib?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Lonafarnib is usually taken daily with morning and evening meals. Follow your doctor's dosing instructions very carefully.

If you cannot swallow a capsule whole, open it and sprinkle the medicine into 1 to 2 teaspoons of Ora Blend SF, Ora-Plus, orange juice, or applesauce. Swallow the mixture within 10 minutes after mixing. Do not save it for later use.

Do not mix the contents of a lonafarnib capsule with grapefruit juice or Seville orange juice. Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Lonafarnib doses are based on body surface area (height and weight). Your dose needs may change if you gain or lose weight or if you are still growing.

Your doctor may need to check your vision on a regular basis.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if your next dose is due in less than 8 hours. Do not take two doses at one time.

What happens if I overdose?

What should I avoid while taking lonafarnib?

Grapefruit and Seville oranges may interact with lonafarnib and lead to unwanted side effects. Avoid the use of grapefruit products and orange marmalades.

What are the possible side effects of lonafarnib?

• new or worsening vision problems (such as decreased night vision);
• severe ongoing nausea, vomiting, diarrhea;
• loss of appetite that causes weight loss;
• high blood pressure --severe headache, blurred vision, shortness of breath, nosebleeds, pounding in your neck or ears;
• kidney problems --little or no urination, swelling in your feet or ankles, feeling tired or short of breath;
• high potassium level --nausea, weakness, tingly feeling, chest pain, irregular heartbeats, loss of movement;
• low potassium level --leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling;
• low sodium level --headache, confusion, slurred speech, severe weakness, vomiting, loss of coordination, feeling unsteady;
• low calcium level --muscle spasms or contractions, numbness or tingly feeling (around your mouth, or in your fingers and toes); or
• signs of infection --fever, chills, cough, rash, swelling, diarrhea, pain or burning when you urinate.

Common side effects may include:

• an electrolyte imbalance (such as low levels of potassium, sodium, or calcium in your blood);
• infection;
• increased blood pressure;
• stomach pain, nausea, vomiting, diarrhea;
• decreased appetite, weight loss;
• headache;
• feeling tired;
• muscle or joint pain;
• cold symptoms such as stuffy nose, sneezing, sore throat, cough; or
• abnormal lab 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 FDA at 1-800-FDA-1088.

What other drugs will affect lonafarnib?

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.

Many drugs can affect lonafarnib. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.

Where can I get more information?

Your doctor or pharmacist can provide more information about lonafarnib.