Peginesatide

Name: Peginesatide

How supplied

Dosage Forms And Strengths

Dosage Form Strengths
Single use vials (preservative-free) 2 mg/0.5 mL, 3 mg/0.5 mL, 4 mg/0.5 mL, 5 mg/0.5 mL, and 6 mg/0.5 mL
Single use pre-filled syringes (preservative-free) 1 mg/0.5 mL, 2 mg/0.5 mL, 3 mg/0.5 mL, 4 mg/0.5 mL, 5 mg/0.5 mL, and 6 mg/0.5 mL
Multiple use vials (with preservative) 10 mg/mL and 20 mg/2 mL

OMONTYS is available in single use vials, single use pre-filled syringes, and multiple use vials. The vial caps and plungers of the pre-filled syringes are designated with unique colors for each dosage strength. The single use pre-filled syringes are supplied with a 27 gauge, ½ inch needle. To reduce the risk of accidental needle sticks after application, each single use pre-filled syringe is equipped with a safety device that activates and covers the needle once the dose has been given.

OMONTYS is available in the following pack sizes:

Single use vials Single use pre-filled syringes with a 27 gauge, ½ inch needle with an UltraSafe Passive® Needle Guard Multiple use vials
1 Vial/Carton 1 Syringe/Carton 1 Vial/Carton
2 mg/0.5 mL
(NDC 64764-602-05) 		1 mg/0.5 mL
(NDC 64764-601-99) 		10 mg/mL
(NDC 64764-610-10)
3 mg/0.5 mL
(NDC 64764-603-05) 		2 mg/0.5 mL
(NDC 64764-602-99) 		20 mg/2 mL
(NDC 64764-620-20)
4 mg/0.5 mL
(NDC 64764-604-05) 		3 mg/0.5 mL
(NDC 64764-603-99) 		 
5 mg/0.5 mL
(NDC 64764-605-05) 		4 mg/0.5 mL
(NDC 64764-604-99) 		 
6 mg/0.5 mL
(NDC 64764-606-05) 		5 mg/0.5 mL
(NDC 64764-605-99) 		 
  6 mg/0.5 mL
(NDC 64764-606-99) 		 

Stability and Storage

The recommended storage temperature is refrigerated at 2 °C to 8 °C (36 °F to 46 °F). Protect from light. Retain in carton until time of use.

Storage of single use vials, single use pre-filled syringes or multiple use vials over the recommended temperature (2 °C to 8 °C), when necessary, is permissible only for temperatures up to 25 °C (77 °F) and for no more than 30 days.

After first use, the multiple use vials should be stored at 2 °C to 8 °C, and then discarded after 28 days.

Marketed by: Affymax, Inc. Palo Alto, CA 94304. Distributed and Marketed by: Takeda Pharmaceuticals America, Inc. Deerfield, IL 60015. Revised: December 2012

Warnings

Included as part of the PRECAUTIONS section.

What should i discuss with my healthcare provider before using peginesatide (omontys)?

You should not use this medication if you are allergic to peginesatide, or if you have untreated or uncontrolled high blood pressure.

To make sure you can safely use peginesatide, tell your doctor if you have any of these other conditions:

  • heart disease, congestive heart failure, or high blood pressure (hypertension);
  • a history of stroke, heart attack, or blood clot;
  • a blood cell or clotting disorder, such as sickle cell anemia or hemophilia;
  • cancer; or
  • epilepsy or another seizure disorder.

FDA pregnancy category C. It is not known whether peginesatide will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether peginesatide passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

  • Anemia
  • Complete Blood Count (CBC)

Side Effects of Peginesatide

Peginesatide may cause serious side effects, including:

  • See "Overview" and "Drug Precautions" sections.
  • serious allergic reactions
  • high blood pressure
  • antibodies to peginesatide

The most common side effects of peginesatide include:

  • shortness of breath
  • diarrhea
  • nausea
  • vomiting
  • cough
  • problems with hemodialysis access
  • headache
  • muscle spasm
  • joint, back, leg, or arm pain
  • low blood pressure (hypotension)
  • fever
  • increase in blood potassium level
  • upper respiratory infection

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

This is not a complete list of peginesatide side effects. Ask your healthcare provider or pharmacist for more information.

You may report side effects to FDA at 1-800-FDA-1088.

 

Peginesatide Interactions

No significant drug interactions have been identified, however, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

 

Peginesatide Food Interactions

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of peginesatide there are no specific foods that you must exclude from your diet when receiving peginesatide.

Forms of Medication

  • Single Use Vials and Single Use Pre-filled Syringes: sorbitol, sodium phosphate monobasic (dihydrate), sodium phosphate dibasic, polysorbate 20, and sodium hydroxide in Water for Injection.
  • Multiple Use Vials: sorbitol, phenol, L-methionine, glacial acetic acid, and sodium hydroxide in Water for Injection.

Other Requirements

  • Keep peginesatide in the original package.
  • Protect peginesatide from light.
  • Store peginesatide in the refrigerator between 36 °F to 46 °F (2 °C to 8 °C).
  • If a refrigerator is not available, peginesatide vials and pre-filled syringes can be stored at 77 °F or less (25 °C or less) for up to 30 days.
  • Throw away multiple use vials of peginesatide no later than 28 days from the first day that you put a needle into the vial.
  • Peginesatide single use vials and pre-filled syringes should be used only one time. Dispose of the single use vial and the pre-filled syringe after use even if there is medicine left in the container.

Keep peginesatide and all medicines out of the reach of children.

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