1 What is Omontys?

Brand: Omontys

Generic: Peginesatide

Omontys injection is an erythropoietic agent used for the treatment of anemia in patients with chronic kidney disease who are on dialysis.

This drug required a prescription and was voluntarily withdrawn from the U.S. market on February 24, 2013, due to safety concerns for serious allergic reactions.

2 What to Know Before Using

Before using Omontys, you must know all about the risks and complications associated with it. Inform your healthcare provider for any allergic reactions to these drugs or any other drugs, foods, dyes, preservatives, or animals. Carefully read the label of non-prescription drugs for any possible allergic reaction or contraindications.

Studies in children regarding the correlation of age to the effects of peginesatide injection have not been performed while safety and efficacy have not been established. Studies in the elderly have not demonstrated any geriatric-specific problems that would limit the utility of peginesatide injection. Adverse effects have been reported in animal studies but studies in pregnant women or animals are still inadequate.

Infant risk is still undetermined when using this drug during breastfeeding. Discuss with your healthcare professional about the potential risks and benefits of taking this drug while breastfeeding. Drugs should not be taken together to prevent any interactions but in necessary cases inquire your healthcare provider regarding the adjustments in dosage or any other necessary precautions to prevent any unwanted side effects.

Inform your healthcare professional if you are taking any other prescription or nonprescription drugs. Intake of specific food or using alcohol or tobacco with this drug is associated with an increased risk of certain side effects. Your healthcare professional can give you special instructions about the use of food, alcohol, or tobacco.

Inform your healthcare provider for any other medical problems such as:

  • Bleeding problems
  • Inflammatory or metabolic conditions
  • Vitamin deficiency
  • Blood clots
  • Congestive heart failure
  • Heart attack
  • Heart bypass surgery
  • Cardiovascular disease
  • Orthopedic procedure
  • Stroke
  • Hypertension
  • or Seizures

3 Proper Usage

Proper usage of Omontys requires strict adherence to your doctor’s orders. This drug is usually injected by a healthcare professional. You will be educated on how to administer this drug at home. This drug is available in 3 forms:

  • Single-use vial
  • Single-use prefilled syringe
  • Multiple-use vials

This drug may be injected under your skin or into a vein. Inject this drug as directed by your healthcare professional. A new needle, unopened vial, or syringe must be used each time you inject your drug if you are injecting this drug at home. Follow the exact dose as prescribed by your healthcare professional tells you to. You will be shown the body areas where this shot can be given.

Used needles and syringes must be disposed of in a hard, closed puncture-resistant container. Keep this container away from children and pets. You might not use the entire drug in each vial or syringe. The single-use vial or syringe must only be used one time. Saving an open single-use vial or syringe is not recommended. Do not use the drug if the vial or syringe has changed color, or if you see particles in it.

The dose of this drug will be variable for different patients. The directions on the label or the prescription by your healthcare professional should be followed. The dosage of this drug you take depends on the medical problem for which you are using this drug. The dose in adults with anemia from chronic kidney failure is based on body weight and must be determined by your healthcare professional.

The starting dose is 0.04 milligram per kilogram of body weight injected into a vein or under the skin once a month. Your healthcare professional may adjust the dose if necessary. Use and dose in children must be determined by your healthcare professional.

A missed dose should be taken as soon as possible. However, skip the missed dose and go back to your regular dosing schedule if it is almost time for your next dose.

Store the drug in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing. Keep out of the reach of children. Dispose any outdated or expired drugs and ask your healthcare professional for the proper disposal of the drugs.

4 Precautions to Take

Before using Omontys, there are some precautions you must take. Regular visits should be made to your healthcare provider to track your progress and to monitor the effectiveness of the drug.

Your blood pressure will also be monitored during and after treatment with this drug. Consult with your healthcare professional immediately if you notice any change to your recommended blood pressure.

Seek immediate medical attention if you have symptoms of anaphylaxis such as:

  • Rash
  • Itching
  • Swelling of the face, tongue, and throat
  • Trouble with breathing
  • or Chest pain after you receive the drug

This drug may increase your risk of having heart attack, stroke, congestive heart failure, and blood clotting problems. Check with your healthcare professional immediately if you start having dizziness, fainting spells, severe tiredness, chest pain, trouble with breathing, sudden or a severe headache, or problems with vision, speech, or walking.

This drug sometimes causes convulsions, especially during the first few months of treatment. Talk with your healthcare professional if you have concerns about this. People with hypertension or kidney problems are required to have a special diet to keep their blood pressure under control.

An increase in appetite has been associated after correction of their anemia. It is very important that you follow your special diet and take your drugs regularly to prevent your kidney disease or your high blood pressure from getting worse. Your healthcare professional may direct you to take iron or vitamin supplements.

5 Potential Side Effects

As with many medications, there are several potential side effects associated with Omontys. Side effects may vary for each individual and prompt medical attention should be given if they occur.

Seek advice from your healthcare professional immediately if you experience any unusual symptoms such as:

  • Abdominal or stomach pain
  • Blurred vision
  • Body aches or pain
  • Chills
  • Confusion
  • Cough
  • Difficulty with breathing
  • Dizziness
  • Faintness
  • Lightheadedness when getting up suddenly from a lying or sitting position
  • Ear congestion
  • Fever
  • Headache
  • Irregular heartbeat
  • Loss of voice
  • Nasal congestion
  • Nausea or vomiting
  • Nervousness
  • Numbness or tingling in the hands
  • Feet, or lips
  • Pounding in the ears
  • Runny nose
  • Shortness of breath
  • Slow or fast heartbeat
  • Sneezing
  • Sore throat
  • Sweating
  • Unusual tiredness or weakness
  • Weakness or heaviness of the legs
  • Back pain
  • Chest tightness
  • Chills
  • Difficulty with swallowing
  • Flushing
  • Hives
  • Itching
  • Puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • Seizures
  • Skin rash
  • Trouble breathing
  • or Weakness

Some side effects may occur that usually do not need medical attention. As your body adjusts to the medicine, the side effects will slowly disappear. Ask your healthcare professional about ways to prevent or reduce some of these side effects.

If any of the following side effects persists or are inconvenient, or if you notice any other effects, or if you have any questions about them, consult with your health care professional. Report any side effects to the FDA hotline at 1-800-FDA-1088.