IMPORTANT SAFETY INFORMATION

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Drisdol^® (ergocalciferol, USP) Capsules

WHAT ARE DRISDOL CAPSULES USED FOR?

Drisdol^® (ergocalciferol, USP) capsules are used to treat hypoparathyroidism (low levels of parathyroid hormone), which result in calcium and phosphorus deficiencies, refractory rickets, also known as vitamin D resistant rickets, and inherited phosphate deficiency.

WHEN SHOULD I NOT TAKE THE DRUG?

Do not take Drisdol capsules if you have ever had an allergic reaction to vitamin D or, if you have:

• High levels of calcium in your blood (hypercalcemia)
• High levels of vitamin D in your body (hypervitaminosis)
• Any condition that makes it hard for your body to absorb nutrients from food (malabsorption)

WHAT WARNINGS SHOULD I KNOW ABOUT DRISDOL CAPSULES?

Vitamin D should be strictly restricted in infants that have excessive calcium levels from unknown causes.

KEEP OUT OF REACH OF CHILDREN

Care should be taken to consider all sources of vitamin D, including from fortified foods, dietary supplements, and prescription drugs. Too much vitamin D can result in vitamin D toxicity. Your doctor must evaluate you and determine your dosage of Drisdol capsules based on the total amount of vitamin D you are getting from all sources.

If you are taking Drisdol capsules for the treatment of vitamin D resistant rickets, you should be aware that there is a very narrow range in the dose you can receive where it will help you versus the dose that is toxic.

If you have low levels of parathyroid hormone, your doctor may prescribe other treatments, including calcium injection, parathyroid hormone, and/or dihydrotachysterol.

Your doctor will monitor the phosphorus levels in your body and may prescribe supplementation to maintain normal phosphorus levels.

Excessive vitamin D during pregnancy has been shown to cause fetal abnormalities. Therefore, use of vitamin D in doses above the recommended dietary amount should be avoided unless your doctor believes  that the benefit clearly outweighs the risk of taking the medicine.

Your doctor will only prescribe Drisdol capsules with caution if you are nursing, as large doses of vitamin D have been shown to pass through to breast milk.

The dose of vitamin D given to children must be individualized for the specific patient.

Older patients may absorb vitamin D more quickly than younger patients.  If you are older, your doctor may start you on a low dose of Drisdol capsules and slowly increase your dose based on your response.

WHAT SHOULD I TELL MY HEALTHCARE PROVIDER?

To make sure that you can safely take Drisdol capsules, tell your doctor if you have any of these conditions:

• Heart disease
• Coronary artery disease
• Kidney disease
• An electrolyte imbalance, including high phosphate levels
• A calcium imbalance

You should also tell your doctor:

• If you are pregnant, planning to become pregnant or are breast feeding
• If you are taking prescription or nonprescription medicines, herbal preparations or dietary supplements
• If you have allergies to medicines, foods or other substances

WHAT OTHER MEDICATIONS MIGHT INTERACT WITH DRISDOL CAPSULES?

Mineral oil interferes with the absorption of Drisdol capsules into your body

If you are taking diuretics containing thiazide to treat low levels of parathyroid hormone, Drisdol capsules may cause an excessive increase in the amount of calcium in your body.

WHAT ARE THE SIDE EFFECTS OF DRISDOL CAPSULES?

Seek medical attention if you have any of these side effects:

• Brittle bones
• Chills
• Diarrhea
• Dry mouth
• Excessive thirst
• Excessive urination
• Growth suppression in children
• Headache
• Mental retardation
• Metallic taste in your mouth
• Muscle or bone pain
• Stomach cramps
• Vomiting

SEEK EMERGENCY MEDICAL HELP IF YOU HAVE:

• Severe allergic reactions (rash, hives, difficulty breathing, tightness in the chest, swelling of the mouth, face, lips or tongue)

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to Validus Pharmaceuticals LLC at 1-866-982-5438.

WHAT IF I OVERDOSE?

Contact 1-800-222-1222 (Poison Control Hotline) or go to the emergency room immediately if you suspect that you have an overdose of Drisdol Capsules.

If you have vitamin D toxicity with high calcium levels in your blood, immediately stop vitamin D treatment, follow a low calcium diet, and drink a lot of fluids.

Excessive calcium levels can cause dehydration, stupor, coma, and high nitrogen levels in the blood. Treatment of excessive calcium is hydration (usually by IV) to increase calcium excretion through the urine.

With appropriate therapy, recovery from overdose is the usual outcome and no permanent damage will occur, although death via kidney and heart failure has occurred.

The effects of excessive vitamin D can last for 2 months after treatment.

To report SUSPECTED ADVERSE REACTIONS, contact Validus Pharmaceuticals, LLC at — VALIDUS (1-866-982-5438) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch