Lonafarnib

WHY is this medicine prescribed?

Lonafarnib is used to reduce the risk of death in children 1 year of age or older with Hutchinson-Gilford progeria syndrome (HGPS, Hutchinson-Gilford syndrome; an inherited disorder that causes certain proteins to build up in the body which causes children to age rapidly). Lonafarnib is also used to treat certain processing-deficient progeroid laminopathies (PDPL; inherited disorders that cause certain proteins to build up in the body which cause children to age rapidly). Lonafarnib is in a class of medications called farnesyltransferase inhibitors. It works by preventing proteins from building up and damaging cells.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Lonafarnib comes as a capsule to take by mouth. It is usually taken with food twice a day in the morning and evening with meals. Take lonafarnib at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take lonafarnib exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the capsules whole with water; do not chew or crush them.

If you cannot swallow capsules whole, you may open the capsules and sprinkle the contents over 1 or 2 teaspoons (5 or 10 mL) of Ora Blend SF, Ora-Plus, orange juice, or applesauce in a medicine cup, stir the mixture with a spoon, and swallow the mixture immediately (within 10 minutes) as part of your meal.

Your doctor will probably start you on a low dose of lonafarnib and increase your dose after 4 months.

Lonafarnib may cause nausea, vomiting, or diarrhea that can lead to dehydration and weight loss. Your doctor may decrease your dose if you experience persistent vomiting or diarrhea. Be sure to tell your doctor how you are feeling during your treatment with lonafarnib.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before taking lonafarnib,

• tell your doctor and pharmacist if you are allergic to lonafarnib, any other medications, or any of the ingredients in lonafarnib capsules. Ask your pharmacist for a list of the ingredients.

• tell your doctor if you are taking amiodarone (Nexterone, Pacerone), aprepitant (Emend), atorvastatin (Lipitor, in Caduet), ceritinib (Zykadia), clarithromycin, diltiazem (Cardizem, Cartia, Tiazac, others), erythromycin (E.E.S., E-Mycin, Erythrocin), idelalisib (Zydelig), itraconazole (Sporanox, Tolsura), ketoconazole, lovastatin (Altoprev), midazolam (Nayzilam, Seizalam), nefazodone, nelfinavir (Viracept), ribociclib (Kisqali), rifampin (Rifadin, Rimactane), ritonavir (Norvir, in Kaletra), saquinavir (Fortovase, Invirase), simvastatin (Flolipid, Zocor, in Vytorin), tucatinib (Tukysa), and voriconazole (Vfend). Your doctor may tell you not to take lonafarnib if you are taking one or more of these medications.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: atomoxetine (Strattera); cimetidine (Tagamet), dabigatran (Pradaxa), digoxin (Lanoxin), entrectinib (Rozlytrek), esomeprazole (Nexium, in Vimovo), fexofenadine (in Allegra-D), fluconazole (Difulcan), lesinurad (Zurampic), loperamide (Imodium A-D), metronidazole (Flagyl, in Pylera), omeprazole (Prilsec, Zegerid, in Talicia), pantoprazole (Protonix), and simeprevir. Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with lonafarnib, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.

• tell your doctor if you have or have ever had high blood pressure; high blood levels of calcium or potassium; low blood levels of sodium, potassium, or bicarbonate; low blood cell counts (leukopenia, lymphopenia, neutropenia, anemia); or eye, kidney or liver problems.

• Tell your doctor if you are pregnant or plan to become pregnant. Lonafarnib may harm your unborn baby. You should use birth control to prevent pregnancy during your treatment. Talk to your doctor about birth control methods that will work for you. If you become pregnant during your treatment with a lonafarnib, call your doctor immediately.

• tell your doctor if you are breast-feeding.

• you should know that this medication may decrease fertility in men and women.

What SPECIAL DIETARY instructions should I follow?

Do not eat grapefruit or Seville oranges or drink grapefruit juice while taking this medication.

What should I do IF I FORGET to take a dose?

If you remember the missed dose within 8 hours of the time you were scheduled to take it, take the missed dose right away with food. However, if more than 8 hours have passed since the scheduled time, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Lonafarnib may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• vomiting
• diarrhea
• nausea
• stomach pain
• constipation
• gas
• decreased appetite
• decreased weight
• tiredness
• muscle, joint, and bone pain
• headache
• fever
• runny nose
• cough
• rash
• itching

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• headaches, shortness of breath, nosebleeds, flushing, dizziness, or chest pain
• vision changes
• watery, red, itchy eyes
• decreased urine output

Lonafarnib may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests and eye exams, and will monitor your blood pressure during your treatment with lonafarnib.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking lonafarnib.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.