Lipo-C Injection

Important Safety Information — Lipo-C Injection

Regulatory status

Not FDA-approved for any use. No lipotropic (MIC) injection, with or without L-carnitine or B vitamins, is FDA-approved for weight loss or any other use. On its own, levocarnitine (L-carnitine) injection is FDA-approved for carnitine deficiency caused by certain inherited metabolic disorders and for carnitine deficiency in people with end-stage kidney disease on dialysis, and cyanocobalamin (vitamin B12) injection, an ingredient in some Lipo-C formulas, is FDA-approved for B12 deficiency caused by poor absorption. Those approvals apply to the single-ingredient products, not to this compounded blend. A licensed provider reviews your health history, current medicines and goals, explains what is and is not known, and decides whether it may be appropriate for you.

Do not use if

• You are allergic to methionine, inositol, choline, L-carnitine or any other ingredient in the compounded preparation
• Your formula contains vitamin B12 and you are sensitive (allergic) to cobalt or vitamin B12

Before starting, tell your provider if

• You have a seizure disorder or have ever had a seizure
• You have kidney disease or are on dialysis (L-carnitine can cause muscle weakness in people with uremia, and its byproducts can build up when the kidneys do not work well)
• You take warfarin (an increase in INR, a blood-clotting test, has been reported with levocarnitine)
• You take valproic acid or other seizure medicines such as phenobarbital, phenytoin or carbamazepine (these can lower carnitine levels)
• Your formula contains vitamin B12 and you have Leber's disease (hereditary optic nerve atrophy)
• You take any prescription or over-the-counter medicines, vitamins or supplements, including folic acid or other B vitamins
• You have had an allergic reaction to any medicine
• You are pregnant, plan to become pregnant or are breastfeeding

Serious side effects — get medical help right away

• Serious allergic reactions (anaphylaxis). Serious allergic reactions, including anaphylaxis, swelling of the voice box (laryngeal edema) and tightening of the airways (bronchospasm), have been reported with levocarnitine, mostly in people on dialysis, and anaphylactic shock and death have been reported after vitamin B12 injections. Stop using Lipo-C and get emergency help (call 911) for swelling of the face, lips, tongue or throat, trouble breathing or swallowing, or a widespread rash or hives.
• Seizures. Seizures have been reported in people receiving levocarnitine, with or without a history of seizures, and people who already have seizures have reported more frequent or more severe seizures. Get emergency help (call 911) for a seizure.
• Optic nerve damage in Leber's disease (formulas with vitamin B12). People with early Leber's disease (hereditary optic nerve atrophy) who were treated with cyanocobalamin have had severe and rapid optic nerve damage.

Common side effects

Common side effects: the side effects of the combined Lipo-C injection have not been well studied, and the FDA has not reviewed its safety. For levocarnitine, the FDA label reports short-lived nausea and vomiting and, less often, body odor and stomach inflammation (gastritis). High intakes of choline have been linked to a fishy body odor, vomiting, excessive sweating and salivation, and low blood pressure. If your formula contains vitamin B12, mild, short-lived diarrhea, itching and a temporary rash have been reported with B12 injection. Tell your provider about any reaction where the injection is given, or any new symptom. These are not all the possible side effects.

You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Pregnancy and breastfeeding

There are no adequate and well-controlled studies of levocarnitine in pregnant women, and its use while breastfeeding has not been specifically studied. There is no FDA-reviewed information on the combined Lipo-C injection during pregnancy or breastfeeding. Tell your provider if you are pregnant, plan to become pregnant or are breastfeeding.

The exact ingredients in Lipo-C differ between pharmacies. Check the pharmacy label of your preparation, and ask your provider or the pharmacy about any ingredient you are unsure of.

Prescription only. Lipo-C is available only after an online visit with a licensed provider, who determines whether treatment is appropriate for you. This summary does not replace the full prescribing information. Not medical advice. Results may vary.