Denovo

Folate is a type of B vitamin found naturally in many foods. Folic acid is the synthetic version of folate that is added to processed foods or vitamin and mineral supplements. The body needs folate to make red blood cells.

Not having enough folate (a deficiency) can happen due to certain diseases, some medications, or not getting enough folate in your diet. A folate deficiency can result in fewer red blood cells, known as anemia. It can also lead to high levels of a specific amino acid in the blood, a condition called hyperhomocysteinemia (HYE-per-HOE-moe-sis-tin-EE-mee-a).

Denovo is a medical food designed for people with conditions related to folate deficiency. It is also used for individuals with major depressive disorder who have folate deficiency, or for those with schizophrenia who have hyperhomocysteinemia due to folate deficiency.

Denovo is not an antidepressant or anti-psychotic medication. However, it may increase the effects of antidepressant medications.

Denovo may also be used for purposes not mentioned in this medication guide.

Follow all directions on your prescription label. Do not take Denovo in larger or smaller amounts or for longer than recommended.

Use only the strength of l-methylfolate that your doctor has prescribed. Do not switch brands without your doctor's advice.

You may take Denovo with or without food. Follow your doctor's instructions.

Do not crush, chew, or break an extended-release tablet. Swallow it whole.

Do not share this medication with another person, even if they have the same symptoms you have.

Denovo is only part of a complete program of treatment that may also include other medications and psychological counseling when used in people with depression or schizophrenia. Follow your medication and counseling routines very closely.

Store at cool room temperature away from moisture, heat, and light.

Follow all instructions on your medicine label and package. Inform all your healthcare providers about your medical conditions, allergies, and all medicines you are using.

You should not use Denovo if you are allergic to it.

To ensure Denovo is safe for you, inform your doctor if you have:

• seizures or epilepsy;
• a history of vitamin B12 deficiency or pernicious anemia; or
• a history of bipolar disorder (manic depression).

Let your doctor know if you are pregnant or breast-feeding. Your dosage may need to change during pregnancy or while you are nursing.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Less serious side effects may happen, and you may not experience any at all.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You can report side effects to the FDA at 1-800-FDA-1088.

Take the missed dose as soon as you remember. If it is almost time for your next scheduled dose, skip the missed dose. Do not take extra medicine to make up for the missed dose.

An overdose of Denovo is unlikely to cause life-threatening symptoms.

Follow your doctor's instructions regarding any restrictions on food, drinks, or activities.

Tell your doctor about all your current medicines and any you start or stop using, especially:

• capecitabine;
• fluoxetine (Prozac);
• isotretinoin;
• methotrexate;
• methylprednisolone;
• pancrelipase;
• pyrimethamine;
• triamterene;
• trimethoprim;
• warfarin (Coumadin, Jantoven);
• birth control pills;
• oral diabetes medicine that contains metformin (Glucophage, Avandamet, Metaglip, and others);
• NSAIDs (nonsteroidal anti-inflammatory drugs)--aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others; or
• seizure medicine--carbamazepine, lamotrigine, phenobarbital, phenytoin, primidone, valproic acid.

This list is not complete. Other drugs may interact with l-methylfolate, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.