Wyeth BioPharma Division of Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc.
This patient package insert contains information and directions for patients and their caregivers who are getting or giving injections of Neumega at home. You should read this patient information each time you pick up your prescription in case new information has been added. This patient package insert does not take the place of talking with your doctor or other healthcare provider. If you have any questions about your treatment with Neumega you should talk to your doctor.
Neumega is a medicine that stimulates your body to make platelets, which are a type of blood cell. Neumega is for people who have received certain types of chemotherapy and is used to help prevent the number of platelets circulating in the blood from dropping dangerously low. Too few platelets can cause serious problems and even death. Platelets are needed to help clot your blood when you are cut or injured. People with very low platelet counts are more likely to bruise and may not be able to control their bleeding if they are cut or injured. Platelets that have been donated by other people (platelet transfusions) are often given to patients with very low platelet counts. Neumega may reduce the need for platelet transfusions after chemotherapy. If your platelet levels are still too low after taking Neumega, your doctor may recommend that you receive a platelet transfusion.
Neumega can cause serious allergic reactions in some patients. Signs that you are having a serious allergic reaction include: swelling of your face, tongue or throat; difficulty breathing, swallowing or talking; shortness of breath; wheezing; chest pain; a tightness in your throat; feeling lightheaded; loss of consciousness; confusion; drowsiness; rash; itching; hives; flushing and/or fever. You or your caregiver should call your doctor immediately if you develop any of these signs or symptoms.
Neumega can cause heart problems in some patients. If you feel like your heart is pounding, beating fast or skipping a beat, or you have chest pains or are short of breath, you should call your doctor immediately. If you have ever had heart problems, you should tell your doctor before you start treatment with Neumega.
If you are taking a water pill (diuretic), you should tell your doctor, because the diuretic can cause your body to lose potassium. This is very important, because Neumega can cause heart problems and these heart problems could be more serious when the potassium in your blood is too low. Your doctor will be checking your blood for the amount of potassium in it. If your potassium level is low, your doctor may prescribe a potassium replacement medication to correct it.
Neumega may cause you to retain water and gain weight from the extra fluid in your body. For some patients, water weight gain may cause serious problems that require medicine or hospitalization. A small amount of water weight gain will usually go away within several days after you stop taking Neumega. But, if you have a rapid weight gain over a few days, swelling of the legs and feet, dizziness, shortness of breath or chest pain, it could mean that you have a serious condition with fluid around the lungs and heart. If you have ever had heart failure or are taking medicine that may cause you to retain water, you should tell your doctor before you start treatment with Neumega.
Neumega can cause or worsen an eye problem called papilledema. Papilledema is swelling of the optic (eye) nerve. Papilledema can cause changes in your eyesight from blurred vision to blindness.
Because Neumega is approved only for use in adults, you should talk to your child's doctor about the reasons why Neumega has been prescribed for your child. You should talk to your child's doctor about the risks and side effects of using this medication in children. One of the side effects seen in children taking Neumega is a serious eye condition called papilledema which is a form of swelling of the nerve that enters the back of the eye. Many children may not show any signs of papilledema. If your child complains that they have a headache or are having difficulty seeing, call your child's doctor right away. Other side effects that have been seen in children are fast heartbeat, redness of the eye, changes to the heart, and changes to bones that can be seen on x-ray.
Before you start taking Neumega, you should tell your doctor the names of all of the medications you are taking including prescription and non-prescription drugs, vitamins, and nutritional supplements. If you have any of the following conditions or medical problems, tell your doctor or healthcare provider:
Do not take Neumega if you have ever had or think you have had an allergic reaction to Neumega. Talk to your doctor if you have any questions about this information.
The most common, but less serious side effects, are:
These side effects may be caused by water retention. For most people, the water weight gain will go away a few days after the last injection of Neumega. Make sure you have read and understand the section called "What is the most important information I should know about Neumega?", because many of these side effects could develop into a more serious condition.
Other side effects that you should tell your doctor about are:
If you have any other problems, whether or not you think they are related to Neumega, you should call your doctor.
To see if Neumega is working, your doctor will ask you to have blood tests done to measure the number of platelets in your body. After starting Neumega, it may take 10 to 21 days for your platelet numbers to increase. The amount of time it takes to increase the number of platelets varies from patient to patient. Neumega may not work for everyone and you may still need platelet transfusions or have bleeding even if you take Neumega as directed by your doctor. You should always follow your doctor's instructions.
If your doctor has recommended that you receive Neumega at home, then you and/or your caregiver should be instructed on how to prepare Neumega, how much Neumega to use, how to inject it, how often it should be injected, and how to dispose of the unused portions of each bottle. Do not inject Neumega until you are comfortable with the steps to prepare and inject Neumega at home.
It is important that you do not take any more or less of the amount of Neumega that your doctor prescribed. Too much Neumega might put you at risk for irregular heartbeats and water retention (including fluid around the heart and lungs). If you accidentally take too much Neumega, you should call your doctor immediately.
You should always change the site of your injections each day to avoid soreness at any one site. Your injections should be given about the same time each day. If you miss an injection on one day, you should not try to add it on the next day. Tell your doctor that you missed a dose and continue as usual with your next scheduled dose. The section "How Do I Give Myself Neumega?" gives you step-by-step instructions for preparing and injecting your dose of Neumega.
Please read all the instructions carefully to be sure you understand the procedure before you prepare and give the injection.
One needle to use with the pre-filled syringe of Sterile Water for Injection, USP: 23 to 25 gauge, ¾ to 1 inch needle
One needle to use with the 1 mL (1 cc) syringe: 25 to 26 gauge, ½ to 1 inch needle
Look for the expiration date printed on the Neumega bottle and pre-filled syringe. Do not use the Neumega powder or the pre-filled syringe if the current month and year is after the month and year on the bottle or pre-filled syringe; this means that the Neumega or pre-filled syringe have expired. Tell your doctor that the Neumega and/or the pre-filled syringe have expired and that you need replacements. If the Neumega powder and the pre-filled syringe have not expired, then continue with the steps that follow.
Wash your hands with soap and water. [picture]
Check the fluid inside the bottle. It should be clear and colorless without any powder or specks. Do not inject the Neumega if the fluid is cloudy or colored or if you see any particles. Call your doctor, nurse or pharmacist for instructions on what to do with a bottle of Neumega that you cannot use.
You should use the Neumega mixed with the Sterile Water for Injection, USP as soon after mixing it as possible. Do not let more than three (3) hours go by between the time you mix the Neumega and the water, and the time that you use it. The mixed Neumega and Sterile Water for Injection, USP can be stored in the Neumega bottle for up to three (3) hours either at room temperature or in the refrigerator. Remember to keep the bottle out of the light. Do not store the Neumega and Sterile Water for Injection, USP mixture in a syringe.
Fill the syringe with air by pulling the plunger back to the line or number on the syringe that your doctor or nurse has told you is the right one for the amount of Neumega that you are supposed to take.
Check to be sure that the fluid is still at the line or number that your doctor or nurse has told you is the right one for the amount of Neumega that you are supposed to take. If it is too little, pull the plunger back to the mark. If it is too much, push the plunger in to the mark. Once you are sure you have the right amount, you can go on to step 14.
Always keep the Sharps Container out of the reach of children.
Ask your doctor, nurse, or pharmacist for instructions on how to properly dispose of a full container. There may be special state and local laws for disposal of used needles and syringes.
The kit containing the bottle of powdered Neumega and the pre-filled syringe should be kept in a refrigerator. Do not freeze. The Neumega powder must be protected from light.
Every time you give yourself a dose of Neumega, you must use a new bottle of Neumega powder and a new pre-filled syringe of Sterile Water for Injection, USP. There is an expiration date printed on the bottle of the Neumega powder and on the pre-filled syringe. Do not use the Neumega or the pre-filled syringe if it is past the expiration date (month and year).
After you mix the Neumega with the Sterile Water for Injection, USP, you must use it as soon as possible. Do not let more than three (3) hours go by between the time you mix the Neumega and the water, and the time that you use it. The Neumega and Sterile Water for Injection, USP mixture can be stored in the Neumega bottle for up to three (3) hours either at room temperature or in the refrigerator. Remember to keep the bottle out of the light. Do not store the Neumega and Sterile Water for Injection, USP mixture in a syringe.
After you give yourself an injection of Neumega, discard the Neumega bottle and syringe with the needle attached into the "Sharps Container".
Do not dispose of the Sharps Containers in household trash. Do not recycle.
Medicines are sometimes prescribed for purposes other than those listed here. If you have any questions or concerns about Neumega talk to your doctor. Do not use Neumega for a condition or person other than for whom it is prescribed.
|This product's label may have been updated. For current full prescribing information, please visit www.pfizer.com.|