Udenyca

Udenyca is a prescription medication used to prevent infections in patients receiving anti-cancer drugs that can cause low levels of white blood cells.

Udenyca belongs to a group of drugs called colony stimulating factors. These work by binding to hematopoietic cell (cells that give rise to other blood cells) resulting in increase in their survival, number, and function. This process will overall result in increase in the number of white blood cells in the body.

This medication comes in a subcutaneous (under the skin) injection form and is taken once per chemotherapy cycle.

Common side effects of Udencya include bone pain and pain in the extremities.

Udenyca is a man-made form of granulocyte colony-stimulating factor (G-CSF). G-CSF is a substance produced by the body. It stimulates the growth of neutrophils, a type of white blood cell important in the body’s fight against infection.

Udenyca is a prescription medication used to prevent infections in patients with non-myeloid (not related to the bone marrow) cancers who are receiving bone marrow suppressing anti-cancer drugs that are associated with significant occurrence of fever with low neutrophil count (febrile neutropenia).

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Udenyca. See the “Udenyca Precautions” section.

Common side effects of Udencya include the following:

• pain in the bones, arms, and legs.

This is not a complete list of Udencya side effects. Ask your doctor or pharmacist for more information. Tell your doctor if you have any side effects that bother you or that do not go away. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088

No drug interactions for Udenyca have been evaluated by the manufacturer. 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.

Serious side effects have been reported with Udenyca including the following:

• Spleen rupture. Your spleen may become enlarged and can rupture. A ruptured spleen can cause death. Call your healthcare provider right away if you have pain in the left upper stomach area or your left shoulder.
• A serious lung problem called Acute Respiratory Distress Syndrome (ARDS).Call your healthcare provider or get emergency care right away if you have shortness of breath with or without a fever, trouble breathing, or a fast rate of breathing.
• Serious allergic reactions. Udenyca can cause serious allergic reactions. These reactions can cause a rash over your whole body, shortness of breath, wheezing, dizziness, swelling around your mouth or eyes, fast heart rate, and sweating. If you have any of these symptoms, stop using Udenyca and call your healthcare provider or get emergency medical help right away.
• Sickle cell crises. You may have a serious sickle cell crisis if you have a sickle cell disorder and receive Udenyca. Serious sickle cell crises have happened in people with sickle cell disorders receiving pegfilgrastim that has sometimes led to death. Call your healthcare provider right away if you have symptoms of sickle cell crisis such as pain or difficulty breathing.
• Kidney injury (glomerulonephritis). Udenyca can cause kidney injury. Call your healthcare provider right away if you develop any of the following symptoms:
  • swelling of your face or ankles
  • blood in your urine or dark colored urine
  • you urinate less than usual
• Increased white blood cell count (leukocytosis). Your healthcare provider will check your blood during treatment with Udenyca.
• Capillary Leak Syndrome. Udenyca can cause fluid to leak from blood vessels into your body’s tissues. This condition is called "Capillary Leak Syndrome" (CLS). CLS can quickly cause you to have symptoms that may become life-threatening. Get emergency medical help right away if you develop any of the following symptoms:
  • swelling or puffiness and are urinating less than usual
  • trouble breathing
  • swelling of your stomach-area (abdomen) and feeling of fullness
  • dizziness or feeling faint
  • a general feeling of tiredness
• Inflammation of the aorta (aortitis). Inflammation of the aorta (the large blood vessel that transports blood from the heart to the body) has been reported in patients who received pegfilgrastim. Symptoms may include fever, abdominal pain, feeling tired, and back pain. Call your healthcare provider if you experience these symptoms.

Do not take Udenyca if you:

• Are allergic to Udenyca or to any of its ingredients

• Are allergic to filgrastim products

Medications 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 Udenyca there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Udenyca, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• Are allergic to Udenyca or to any of its ingredients

• Have sickle cell disorder

• Have kidney problems

• Have certain cancers or history of certain cancers

• Are pregnant or plan to become pregnant

• Are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child. Talk to your doctor to evaluate the risk to your unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed..

It is not known if Udenyca crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Udenyca.

• Udenyca is given as an injection under your skin (subcutaneous injection) by a healthcare provider. If your healthcare provider decides that the subcutaneous injections can be given at home by you or your caregiver, follow the detailed "Instructions For Use" that comes with your Udenyca for information on how to prepare and inject a dose of Udenyca.
• You and your caregiver will be shown how to prepare and inject Udenyca before you use it.
• You should not inject a dose of Udenyca to children weighing less than 45 kg from a Udenyca prefilled syringe. A dose less than 0.6 mL (6 mg) cannot be accurately measured using the Udenyca prefilled syringe.
• If you are receiving Udenyca because you are also receiving chemotherapy, the last dose of Udenyca should be injected at least 14 days before and 24 hours after your dose of chemotherapy.
• If you miss a dose of Udenyca, talk to your healthcare provider about when you should give your next dose.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated

• other medical conditions you have

• how you respond to this medication

• your weight

Adults and children weighing more than 45 kg:  The recommended dose of Udenyca (Pegfilgrastim) for the prevention of infections in patients receiving anti-cancer drugs that can cause low levels of white blood cells is 6 mg (0.6 mL) once per chemotherapy cycle.

Children weighing less than 45 kg: Udenyca prefilled syringe is not recommended for used in children weighing less than 45 kg. The prefilled syringe is not designed to allow doses less than 6 mg (0.6 mL).

If you take too much Udenyca, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store Udenya in the refrigerator between 36° to 46°F  2° to 8°C). Discard Udenyca if stored for more than 48 hours at room temperature.

• Keep this and all medicines out of the reach of children.