Prescription Drugs

CLINICAL PHARMACOLOGY No information provided.

DESCRIPTION Velosulin (insulin human) ® BR is a clear solution of insulin in a phosphate buffer. The concentration of this product is 100 units of insulin per milliliter. This human insulin is structurally identical to the insulin produced by the pancreas in the human body. This structural identity is obtained by recombinant-DNA technology utilizing Saccharomyces cerevisiae (bakers' yeast) as the production organism. When a U-100 insulin syringe is used to deliver the insulin, the effect of Velosulin (insulin human) ® BR begins approximately ½ hour after the injection. The effect lasts up to approximately 8 hours with a maximal effect between the 1 st and 3 rd hour. The time course of action of any insulin may vary considerably in different individuals, or at different times in the same individual, or when using an external insulin infusion pump to deliver the insulin. Because of this variation, the time periods listed here should be considered as general guidelines only when using U-100 insulin syringes to deliver the insulin.

INDICATIONS Diabetes mellitus (hyperglycemia). DOSAGE AND ADMINISTRATION EXTERNAL INSULIN INFUSION PUMPS Velosulin (insulin human) BR is indicated for use with external insulin infusion pumps. Novo Nordisk has demonstrated Velosulin (insulin human) BR to be compatible with MiniMed Model 506 external insulin infusion pump, using MiniMed catheters of PolyfinTM and SofsetTM types without Quick Release. MiniMed Models 506, 505, and 507 external insulin infusion pumps are equivalent with regard to insulin compatibility. If you have any questions on how to operate the pump, consult with your physician or diabetes educator. It is important that you follow the instructions in your pump manual. Failure to follow the instructions may result in an inaccurate insulin dose. The pump manual will also help you in the selection, use and sterilization of the appropriate accessories specific to your pump model. Use the correct reservoir and catheter for the pump that you are using to minimize catheter blockage. Follow your external insulin infusion pump instructions for filling a new reservoir making certain that there are no large air bubbles in the syringe or the catheter. Before inserting the needle, use soap and water to clean your hands and the skin of the infusion site to avoid infection. Choose a new site for each new needle. Follow your instructions from your physician or diabetes educator regarding basal infusion rates and mealtime insulin bolus dosages. An insulin bolus should be followed by a meal within 30 minutes. Velosulin (insulin human) BR is for infusion under the skin. It should not be mixed with any other insulin. To get the most benefit from insulin infusion, measure your blood sugar levels regularly. This will also help in detecting any possible malfunction of your insulin pump. Change the catheter tubing, the insulin, and the reservoir every 48 hours. NOTE: In case of pump interruption or failure, switch back to conventional insulin therapy using U-100 syringes and consult with your physician or diabetes educator. Please see the following information: INSTRUCTIONS FOR INJECTION USING U-100 SYRINGES A. PREPARING THE INJECTION Clean your hands and the injection site with soap and water or with alcohol. Wipe the rubber stopper with an alcohol swab. Pull back the plunger of the syringe until the rubber tip reaches the marking for the number of units you will inject. Push the needle of the syringe through the rubber stopper into the vial. Push the plunger all the way in. This inserts air into the vial. Turn the vial and syringe upside down and slowly pull the plunger back to a few units beyond the correct dose. If there are air bubbles, flick the syringe firmly with your finger to raise the air bubbles to the needle, then slowly push the plunger to the correct unit marking. Remove the needle from the vial. B. GIVING THE INJECTION The following areas are suitable for subcutaneous insulin injection: thighs, upper arms, buttocks, or abdomen. Do not change areas without consulting your physician. The actual point of injection should be changed with each injection. Injection sites should be about an inch apart. The injection site should be clean and dry. Pinch up skin area to be injected and hold it firmly. Hold the syringe like a pencil and push the needle quickly and firmly into the pinched-up area. Release the skin and push plunger all the way in to inject insulin beneath the skin. To ensure that all the insulin is injected, keep the needle in the skin for several seconds after the injection with your finger on the plunger. Do not inject into a muscle unless your physician has advised it. You should never inject insulin into a vein. Remove the needle. If slight bleeding occurs, press lightly with a dry cotton swab for a few seconds - do not rub. IMPORTANT Failure to comply with the above instructions and the antiseptic measures may lead to infections at the injection site. Note: You should use the injection technique recommended by your physician. IMPORTANT NOTES A change in the type, strength, species or purity of insulin could require a dosage adjustment. Any change in insulin should be made under medical supervision. You may have learned how to test your urine or your blood for glucose. It is important to do these tests regularly. Monitor your results and make appropriate dosage adjustments. Contact your physician or diabetes educator for assistance. If you have an illness, especially with vomiting or fever, continue taking your insulin. If possible, stay on your regular diet. If you have trouble eating, drink fruit juices, regular soft drinks, or clear soups; if you can, eat small amounts of bland foods. Test your urine for glucose and ketones and if possible, test your blood glucose. Note the results and adjust dosage accordingly or contact your physician or diabetes educator for assistance. If you have severe and prolonged vomiting, seek immediate emergency medical care. You should always carry identification which states that you have diabetes. Always consult with your physician or pharmacist before taking any new medication. Contact your physician if you have any questions about your condition or the use of insulin. HOW SUPPLIED STORAGE Insulin should be stored in a cool place, preferably in a refrigerator, but not in the freezing compartment. Do not use insulin if it has been frozen. Keep the insulin in its carton so that it will stay clean and protected from light. If refrigeration is not possible, the bottle of insulin which you are currently using can be kept unrefrigerated as long as it is kept as cool as possible (below 86°F [30°C]) and away from heat and sunlight. Never use Velosulin (insulin human) Ò BR if it becomes viscous (thickened) or cloudy. Use it only if it is clear and colorless. Never use insulin after the expiration date which is printed on the vial label and carton. Once the vial has been opened, it should be used within four weeks (28 days). (Note: Remove the tamper-resistant cap at first use. If the cap has already been removed, do not use this product and return it to your pharmacy.)

PATIENT INFORMATION INSULIN USE IN DIABETES Your physician has explained that you have diabetes and that your treatment involves the use of insulin or insulin therapy combined with an oral antidiabetic medicine. Insulin is normally produced by the pancreas, a gland that lies behind the stomach. Without insulin, glucose (a simple sugar made from digested food) is trapped in the bloodstream and cannot enter the cells of the body. Some patients who do not make any or enough of their own insulin, or who cannot use the insulin they do make properly, must take insulin by injection in order to control their blood glucose levels. Each case of diabetes is different and requires direct and continued medical supervision. Your physician has told you the type, strength and amount of insulin you should use and the time(s) at which you should administer it, and has also discussed with you a diet and exercise schedule. You should contact your physician if you experience any difficulties or if you have any questions. TYPES OF INSULINS Standard and purified animal insulins as well as human insulins are available. Standard and purified insulins differ in their degree of purification and content of noninsulin material. Standard and purified insulins also vary in species source; they may be of beef, pork, or mixed beef and pork origin. Human insulin is identical in structure to the insulin produced by the human pancreas, and thus differs from animal insulins. Insulins vary in time of action and in strength; see DESCRIPTION for additional information. Your physician has prescribed the insulin that is right for you; be sure you have purchased the correct insulin and check it carefully before you use it.

OVERDOSE INSULIN REACTION Insulin reaction (too little sugar in the blood, also called hypoglycemia) can occur if the external infusion pump delivers too much insulin, if you take too large an insulin bolus, skip meals, exercise or work harder than normal. Hypoglycemia can also happen if you combine insulin therapy and other medications that lower blood glucose, such as oral antidiabetic agents or other prescription and over-the-counter drugs. The symptoms, which usually come on suddenly, are hunger, dizziness, and sweating. Personality change or confusion may also occur. If you drink or eat something right away (a glass of milk or orange juice, or several sugar candies), you can often stop the progression of symptoms. If symptoms persist, call a physician; an insulin reaction can lead to unconsciousness. If a reaction results in loss of consciousness, emergency medical care should be obtained immediately. If you have had repeated reactions or if an insulin reaction has led to a loss of consciousness, contact your physician. Severe hypoglycemia can result in temporary or permanent impairment of brain function and death. In certain cases, the nature and intensity of the warning symptoms of hypoglycemia may change. A few patients have reported that after being transferred to human insulin, the early warning symptoms of hypoglycemia were less pronounced than they had been with animal-source insulin. CONTRAINDICATIONS No information available.

SIDE EFFECTS Insulin allergy occurs very rarely, but when it does, it may cause a serious reaction including a general skin rash over the body, shortness of breath, fast pulse, sweating and a drop in blood pressure. If any of these symptoms develop you should seek emergency medical care. The formation of fatty lumps at the infusion site or injection site is usually a sign of frequent needle insertion at the same site. Remember to choose new infusion sites or injection sites at which to insert each new needle and consult with your physician or diabetes educator if you develop these fatty lumps at the infusion site. The skin at the infusion site or injection site may also become red, swollen and itchy. This is a local reaction. It may occur if needle insertion is not properly made at the infusion site or injection site, or as a result of skin sensitivity to the cleansing solutions or if the patient is allergic to insulin. If you have a local reaction, consult with your physician or diabetes educator. Patients with severe systemic allergic reactions to insulin (i.e. generalized urticaria, angioedema, anaphylaxis) should be skin tested with each new preparation to be used prior to initiation of therapy with that preparation. DRUG INTERACTIONS No information provided.

WARNINGS ANY CHANGE OF INSULIN SHOULD BE MADE CAUTIOUSLY AND ONLY UNDER MEDICAL SUPERVISION. CHANGES IN PURITY, STRENGTH (E.G., U-40, U-100), MANUFACTURER, TYPE (E.G., LENTEâ â NPH, REGULAR) OR SPECIES (BEEF, PORK, BEEF/PORK, HUMAN) MAY RESULT IN THE NEED FOR A CHANGE IN DOSAGE. ADJUSTMENT MAY BE NEEDED WITH THE FIRST DOSE OR OVER A PERIOD OF SEVERAL WEEKS. BE AWARE THAT SYMPTOMS OF HYPOGLYCEMIA (LOW BLOOD GLUCOSE) OR HYPERGLYCEMIA (HIGH BLOOD GLUCOSE) MAY INDICATE THE NEED FOR DOSAGE ADJUSTMENT. PLEASE READ SECTIONS ENTITLED "INSULIN REACTION" AND "DIABETIC KETOACIDOSIS AND COMA". VELOSULIN (insulin human) BR SHOULD NOT BE MIXED WITH ANY OTHER INSULIN SINCE THE BUFFERING AGENT IN VELOSULIN (insulin human) BR MAY INTERACT WITH THE OTHER INSULIN AND RESULT IN A CHANGE OF ACTIVITY. CHANGE THE CATHETER TUBING, THE INSULIN, AND THE RESERVOIR EVERY 48 HOURS. PRECAUTIONS INSULIN REACTION Insulin reaction (too little sugar in the blood, also called hypoglycemia) can occur if the external infusion pump delivers too much insulin, if you take too large an insulin bolus, skip meals, exercise or work harder than normal. Hypoglycemia can also happen if you combine insulin therapy and other medications that lower blood glucose, such as oral antidiabetic agents or other prescription and over-the-counter drugs. The symptoms, which usually come on suddenly, are hunger, dizziness, and sweating. Personality change or confusion may also occur. If you drink or eat something right away (a glass of milk or orange juice, or several sugar candies), you can often stop the progression of symptoms. If symptoms persist, call a physician; an insulin reaction can lead to unconsciousness. If a reaction results in loss of consciousness, emergency medical care should be obtained immediately. If you have had repeated reactions or if an insulin reaction has led to a loss of consciousness, contact your physician. Severe hypoglycemia can result in temporary or permanent impairment of brain function and death. In certain cases, the nature and intensity of the warning symptoms of hypoglycemia may change. A few patients have reported that after being transferred to human insulin, the early warning symptoms of hypoglycemia were less pronounced than they had been with animal-source insulin. DIABETIC KETOACIDOSIS AND COMA Diabetic ketoacidosis may develop if your body has too little insulin. The most common causes are acute illness, infection, failure to take enough insulin by injection, or catheter clogging when used with an external insulin infusion pump. If you are ill, you should check your urine for ketones. The symptoms of diabetic ketoacidosis usually USAGE IN PREGNANCY It is particularly important to maintain good control of your diabetes during pregnancy and special attention must be paid to your diet, exercise and insulin regimens. If you are pregnant or nursing a baby, consult your physician or diabetes educator.