Juxtapid

Drug List

Juxtapid

Drug Name

Juxtapid (Cabazitaxel)

Manufactured By

Sanofi-Aventis U.S. LLC

Drug Savings

Nationwide Prescription Connection (NPC) is an experienced advocacy service that helps connect patients to manufacturer provided free and discount programs. We can help the uninsured, under insured, those in the Medicare gap also known as the "doughnut hole", or even those needing help with expensive co-pays.  Our web site makes it easy for you to enter the medications you are taking, along with some basic patient information, and then finds the program that is right for you.

Nationwide Prescription Connection (NPC) is an experienced advocacy service that helps connect patients to manufacturer provided free and discount programs. We can help the uninsured, under insured, those in the Medicare gap also known as the "doughnut hole", or even those needing help with expensive co-pays.  Our web site makes it easy for you to enter the medications you are taking, along with some basic patient information, and then finds the program that is right for you.

Treats Disease/Condition

Uses

Juxtapid® (lomitapide) capsules is a prescription medicine used along with diet and other lipid-lowering treatments, including low-density lipoprotein (LDL) apheresis where available, in adults with homozygous familial hypercholesterolemia (HoFH) to reduce LDL (“bad”) cholesterol, total cholesterol, a protein that carries bad cholesterol in the blood (apolipoprotein B), and non-high-density lipoprotein cholesterol (non-HDL-C). Studies have not been conducted to tell us whether Juxtapid can help prevent problems from high cholesterol, such as heart attack, stroke, death, or other health problems. Studies have also not been conducted to tell us whether Juxtapid is safe for use in people with high cholesterol who do not have HoFH, including those with heterozygous familial hypercholesterolemia (HeFH).

How To Use

This medicine should come with a Medication Guide. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand. Take this medicine without food, at least 2 hours after the evening meal. Swallow the capsule whole with a glass of water. Do not break, crush, chew, dissolve, or open it. If you cannot swallow the capsules, tell your doctor right away. Carefully follow your doctor's instructions about low-fat diet. This medicine is part of a complete plan for lowering bad cholesterol in your blood. Your doctor may also want you to take supplements (eg, vitamin E, fatty acids) each day while you are using this medicine. This will help prevent stomach problems, such as trouble getting some nutrients into your body. If you are also using cholestyramine (Questran®) or colesevelam (Welchol®), take it at least 4 hours before or after you take this medicine. Do not drink more than 1 alcoholic drink per day with lomitapide. This could cause unwanted effects on the liver. Grapefruit juice should be avoided while taking this medicine.

Side Effects

The most common side effects of Juxtapid are stomach problems including diarrhea, nausea, vomiting, cramps/pain, indigestion, and/or gas. You may be able to reduce your chance of stomach problems by following an eating plan consisting of less than 20% of calories from fat. Juxtapid makes it harder for some fat-soluble nutrients, such as vitamin E and fatty acids, to get into your body. Take supplements that contain fat-soluble vitamins each day while you take Juxtapid. Ask your doctor, nurse, or dietitian how to take them. Tell your doctor if you have any side effect that bothers you or that does not go away. Stop taking Juxtapid and tell your doctor if you have severe diarrhea, especially if you also have lightheadedness, decreased urine output, or tiredness. These are not all the possible side effects of Juxtapid. For more information, speak with your doctor or pharmacist

Drug Interactions

Moderate and Strong CYP3A4 Inhibitors A strong CYP3A4 inhibitor has been shown to increase lomitapide exposure approximately 27-fold [see Clinical Pharmacology (12.3)]. Concomitant use of strong CYP3A4 inhibitors (such as boceprevir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, mibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, tipranavir/ritonavir, voriconazole) with lomitapide is contraindicated. Concomitant use of moderate CYP3A4 inhibitors (such as amprenavir, aprepitant, atazanavir, ciprofloxacin, crizotinib, darunavir/ritonavir, diltiazem, erythromycin, fluconazole, fosamprenavir, imatinib, verapamil) has not been studied, but concomitant use with lomitapide is contraindicated since lomitapide exposure will likely increase significantly in the presence of these inhibitors. Weak CYP3A4 Inhibitors Weak CYP3A4 inhibitors (such as alprazolam, amiodarone, amlodipine, atorvastatin, bicalutamide, cilostazol, cimetidine, cyclosporine, fluoxetine, fluvoxamine, ginkgo, goldenseal, isoniazid, lapatinib, nilotinib, pazopanib, ranitidine, ranolazine, ticagrelor, zileuton) can increase lomitapide exposure approximately 2-fold [see Clinical Pharmacology (12.3)]. When administered with weak CYP3A4 inhibitors, the dose of JUXTAPID should be decreased by half. Careful titration of JUXTAPID may then be considered based on LDL-C response and safety/tolerability to a maximum recommended dosage of 30 mg daily except when coadministered with oral contraceptives, in which case the maximum recommended lomitapide dosage is 40 mg daily Warfarin Lomitapide increases plasma concentrations of both R(+)-warfarin and S(-)-warfarin by approximately 30% and increased the INR 22%. Patients taking warfarin should undergo regular monitoring of INR, particularly after any changes in lomitapide dosage. The dose of warfarin should be adjusted as clinically indicated. Simvastatin and Lovastatin The risk of myopathy, including rhabdomyolysis, with simvastatin and lovastatin monotherapy is dose related. Lomitapide approximately doubles the exposure of simvastatin; therefore, the recommended dose of simvastatin should be reduced by 50% when initiating JUXTAPID [see Clinical Pharmacology (12.3)]. While taking JUXTAPID, limit simvastatin dosage to 20 mg daily (or 40 mg daily for patients who have previously tolerated simvastatin 80 mg daily for at least one year without evidence of muscle toxicity).Simvastatin and Lovastatin The risk of myopathy, including rhabdomyolysis, with simvastatin and lovastatin monotherapy is dose related. Lomitapide approximately doubles the exposure of simvastatin; therefore, the recommended dose of simvastatin should be reduced by 50% when initiating JUXTAPID [see Clinical Pharmacology (12.3)]. While taking JUXTAPID, limit simvastatin dosage to 20 mg daily (or 40 mg daily for patients who have previously tolerated simvastatin 80 mg daily for at least one year without evidence of muscle toxicity). Refer to the simvastatin prescribing information for simvastatin dosing recommendations. Interaction between lovastatin and lomitapide has not been studied. However, the metabolizing enzymes and transporters responsible for the disposition of lovastatin and simvastatin are similar, suggesting that JUXTAPID may increase the exposure of lovastatin; therefore, reducing the dose of lovastatin should be considered when initiating JUXTAPID. 7.5 P-glycoprotein Substrates Lomitapide is an inhibitor of P-glycoprotein (P-gp). Coadministration of lomitapide with P-gp substrates (such as aliskiren, ambrisentan, colchicine, dabigatran etexilate, digoxin, everolimus, fexofenadine, imatinib, lapatinib, maraviroc, nilotinib, posaconazole, ranolazine, saxagliptin, sirolimus, sitagliptin, talinolol, tolvaptan, topotecan) may increase the absorption of P-gp substrates. Dose reduction of the P-gp substrate should be considered when used concomitantly with lomitapide. 7.6 Bile Acid Sequestrants JUXTAPID has not been tested for interaction with bile acid sequestrants. Administration of JUXTAPID and bile acid sequestrants should be separated by at least 4 hours since bile acid sequestrants can interfere with the absorption of oral medications.

In Case of Overdose

If you take too much JUXTAPID, call your doctor right away.

In Case of Missed Dose

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store JUXTAPID at room temperature, between 68°F and 77°F (20°C and 25°C). • Keep JUXTAPID in a tightly closed container. • Keep JUXTAPID capsules dry. • Safely throw away medicine that is out of date or no longer needed. Keep JUXTAPID and all medicines out of the reach of children