Lonafarnib (Oral route)

Pronunciation:

loe-na-FAR-nib

Brand Names:

  • Zokinvy

Dosage Forms:

  • Capsule

Classifications:

Therapeutic—

Endocrine-Metabolic Agent

Uses of This Medicine:

Lonafarnib is used to help reduce the risk of death in patients with Hutchinson-Gilford Progeria Syndrome (HGPS). HGPS is a genetic condition in which patients have a noticeable, rapid appearance of aging beginning in childhood.

Lonafarnib is also used to treat rare genetic disorders called processing-deficient Progeroid Laminopathies in patients with either heterozygous LMNA mutation with progerin-like protein accumulation, or homozygous or compound heterozygous ZMPSTE24 mutations.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of lonafarnib in children younger than 12 months of age. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of lonafarnib in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of This Medicine:

Take this medicine exactly as directed by your doctor. Do not take it more often, and do not take it for a longer time than your doctor ordered. Do not stop taking this medicine without first checking with your doctor.

This medicine usually comes with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor or pharmacist if you have any questions.

Swallow the capsule whole with water. Do not chew it.

It is best to take this medicine with food.

If you cannot swallow the capsule whole, you may open it and mix the medicine with Ora Blend SF®, Ora-Plus®, orange juice, or applesauce. The mixture must be prepared fresh for each dose and taken within at least 10 minutes of mixing.

Do not eat grapefruit or Seville oranges while you are using this medicine. Do not mix this medicine with juice containing grapefruit or Seville oranges.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (capsules):
    • For Hutchinson-Gilford Progeria Syndrome and processing-deficient Progeroid Laminopathies:
      • Adults and children 12 months of age and older with a body surface area (BSA) of 0.39 meter squared (m2)—At first, 115 milligrams per square meter (mg/m[2]), taken 2 times a day with the morning and evening meals. Your doctor may adjust your dose as needed and tolerated.
      • Children younger than 12 months of age—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you miss a dose and it is 8 hours or more of your next scheduled dose, take it as soon as possible, and then go back to your regular schedule. If you miss a dose and it is less than 8 hours of your next scheduled dose, skip the missed dose and take your next dose at the regular time.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant during treatment. If you think you have become pregnant while using the medicine, tell your doctor right away.

Do not use this medicine together with atorvastatin, ketoconazole, lovastatin, rifampin, or simvastatin. Do not use this medicine for 10 to 14 days before and 2 days after using midazolam.

This medicine lowers the number of some types of blood cells in your body. Because of this, you may bleed or get infections more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.

This medicine may cause kidney problems. Check with your doctor right away if you or your child have agitation, blood in the urine, coma, confusion, decreased urine output, depression, dizziness, headache, irritability, lethargy, muscle twitching, nausea, rapid weight gain, seizures, stupor, swelling of the face, ankles, or hands, or unusual tiredness or weakness.

Check with your doctor right away if eye pain or a change in vision occurs during treatment. These could be a sign of a serious eye problem. Your doctor may want your eyes be checked by an ophthalmologist (eye doctor).

Some men and women who use this medicine have become infertile (unable to have children). Talk with your doctor before using this medicine if you plan to have children.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common
Agitation
black, tarry stools
blood in the urine or stools
burning, dry, or itching eyes
changes in the eye
coma
cough or hoarseness
confusion
dark urine
decreased appetite
decreased urine output
depression
diarrhea
discharge, excessive tearing
dizziness
fever
headache
irritability
lethargy
light-colored stools
lower back or side pain
muscle twitching
nausea
painful or difficult urination
pinpoint red spots on the skin
rapid weight gain
redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid
seizures
sore throat
stomach pain or bloating
stupor
swelling of the face, ankles, or hands
unusual bleeding or bruising
unusual tiredness or weakness
vomiting
weight loss
yellow eyes or skin
Less common
Body aches or pain
chills
cough
difficulty in breathing
ear congestion
fever
headache
loss of voice
runny or stuffy nose
sneezing
sore throat

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
Bloated
bloody nose
constipation
excess air or gas in the stomach or bowels
full feeling
passing gas
Less common
Cracked lips
difficulty in swallowing
itching skin
sores, ulcers, or white spots in the lips, tongue, or inside the mouth

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.


Last Updated: 6/2/2022

The information provided herein should not be used during any medical emergency or for the diagnosis or treatment of any medical condition. A licensed medical professional should be consulted for diagnosis and treatment of any and all medical conditions. Call 911 for all medical emergencies. Links to other sites are provided for information only -- they do not constitute endorsements of those other sites.

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The information provided herein should not be used during any medical emergency or for the diagnosis or treatment of any medical condition. A licensed medical professional should be consulted for diagnosis and treatment of any and all medical conditions. Call 911 for all medical emergencies. Links to other sites are provided for information only -- they do not constitute endorsements of those other sites.
All rights reserved.