Oprelvekin Subcutaneous

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For oprelvekin, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to oprelvekin or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Oprelvekin has caused joint and tendon problems in animals and there is a possibility it could also cause these effects in children receiving it. Discuss these possible effects with your doctor.

Geriatric

oprelvekin has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of oprelvekin. Make sure you tell your doctor if you have any other medical problems, especially:

• Congestive heart failure—May be worsened because oprelvekin causes the body to retain water
• Atrial arrhythmias (heart rhythm problems)—oprelvekin may cause heart rhythm problems
• Fluid build-up in the abdomen or lungs—May be worsened by oprelvekin
• Myeloablative chemotherapy— May lead to serious side effects

It is very important that your doctor check your progress at regular visits to make sure that oprelvekin is working properly and to check for unwanted effects.

This medication is used to prevent very low platelet counts (thrombocytopenia) and to reduce the need for platelet transfusions after certain chemotherapy treatments. Platelets help your blood clot when you are cut or injured. Having too few platelets can cause you to bruise easier and/or bleed longer when you get cut or injured. This medication causes your body to make more platelets.

How to use Oprelvekin Solution, Reconstituted (Recon Soln)

Read the Patient Information Leaflet provided by your pharmacist before you start using oprelvekin and each time you get a refill. If you have any questions, consult your doctor or pharmacist.

This medication is injected under the skin of the abdomen, thigh, hip, or upper arm, usually once daily starting 6 to 24 hours after chemotherapy treatment or as directed by your doctor.

Learn all preparation and usage instructions in the Patient Information Leaflet. If any of the information is unclear, consult your doctor or pharmacist.

After mixing the medication, swirl it gently to combine. Do not shake the medication. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid.

Before injecting each dose, clean the injection site with rubbing alcohol. It is important to change the location of the injection site daily to avoid problem areas under the skin.

Dosage and length of treatment is based on your medical condition and response to treatment. It is not recommended to use this medication longer than 21 days for each treatment course.

Use this medication regularly to get the most benefit from it. To help you remember, use it at the same time each day.

Use this medication exactly as prescribed. Do not increase your dose or take this medication more often or longer than prescribed. Your condition will not improve any faster, and the risk of serious side effects may be increased.

The mixed medication or the sterile water for injection that comes with the medication should only be used once. Throw away any unused portion. Learn how to store and throw away needles and medical supplies safely. Consult your pharmacist.

Before using oprelvekin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, heart/blood vessel disease (e.g., congestive heart failure, irregular heartbeat, stroke), unusual fluid retention (e.g., swelling of the ankles/feet, ascites, pleural effusion), eye problems (e.g., papilledema), brain/spinal cord tumors, high blood pressure (hypertension).

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Children may be at greater risk for eye/heart problems and bone changes while using this drug.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk but is unlikely to harm a nursing infant. Consult your doctor before breast-feeding.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: fast/irregular heartbeat, trouble breathing.

Notes

Do not share this medication with others.

Laboratory and/or medical tests (e.g., hemoglobin/hematocrit levels, complete blood count, electrolyte levels) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

Missed Dose

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Storage

Store the vial of powder and sterile water for injection in the refrigerator between 36-46 degrees F (2-8 degrees C) away from light. Do not freeze. The mixed medication should be used within 3 hours and can be stored in the vial, either in the refrigerator at 36-46 degrees F (2-8 degrees C) or at room temperature up to 77 degrees F (25 degrees C). Do not store the medication in a syringe. Throw away any unused portion. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.Information last revised July 2016. Copyright(c) 2016 First Databank, Inc.