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Details with Side Effects
Read this Medication Guide before you start taking SYLATRON, and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking with your healthcare provider about your medical condition or your treatment.
What is the most important information I should know about SYLATRON?
SYLATRON can cause serious mental health problems which can lead to suicide.
SYLATRON may cause you to develop mood or behavior problems that may get worse during treatment with SYLATRON or after your last dose. Call your healthcare provider right away if you, your family, or caregiver notice any of the following:
- irritability (getting upset easily)
- depression (feeling low, feeling bad about yourself, or feeling hopeless)
- aggressive behavior
- thoughts of hurting yourself or others, or thoughts of suicide
Former drug addicts may fall back into drug addiction or overdose.
If you have these symptoms, your healthcare provider should carefully monitor you during treatment with SYLATRON and for 6 months after your last dose.
If symptoms get worse or become severe and continue, your healthcare provider may tell you to stop taking SYLATRON permanently. These signs or symptoms may not go away after you stop taking SYLATRON.
See “What are the possible side effects of SYLATRON?” for more information about side effects.
What is SYLATRON?
SYLATRON is a prescription medicine that is used to prevent malignant melanoma (a kind of skin cancer) from coming back after it has been removed by surgery. SYLATRON should be started within 84 days of surgery to remove lymph nodes containing cancer.
It is not known if SYLATRON is safe and effective in children less than 18 years of age.
Who should not take SYLATRON?
Do not take SYLATRON:
- if you have had a serious allergic reaction to peginterferon alfa-2b or to interferon alfa-2b
- if you have certain types of hepatitis
- if you have severe liver damage
What should I tell my healthcare provider before taking SYLATRON?
Before you take SYLATRON, tell your healthcare provider about all of your health problems, including if you:
- are being treated for a mental illness or had treatment in the past for mental illness, including depression or thoughts of suicide or suicide attempts. See “What is the most important information I should know about SYLATRON?”
- have liver damage from drugs or disease
- have ever been addicted to drugs or alcohol
- have or had an overactive or underactive thyroid gland
- have diabetes
- have any other medical problem(s)
- are pregnant or plan to become pregnant. It is not known if SYLATRON will harm your unborn baby.
- are breastfeeding or plan to breastfeed. You and your healthcare provider should decide if you should use SYLATRON or breastfeed. You should not do both.
Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.
SYLATRON and certain other medicines may affect each other and cause side effects.
Know the medicines you take. Keep a list of them to show your healthcare providers and pharmacists each time you get a new medicine.
You should not start a new medicine before your talk with the healthcare provider who prescribes you SYLATRON.
How should I take SYLATRON?
- Take SYLATRON exactly as your healthcare provider tells you to. Your healthcare provider will tell you how much SYLATRON to take and when to take it.
- Do not take more than your prescribed dose. Call your healthcare provider right away if you take too much SYLATRON.
- Inject SYLATRON one time each week unless instructed differently by your healthcare provider. Call your healthcare provider for instructions if you miss a dose.
- SYLATRON is given as an injection under your skin (subcutaneous injection). Your healthcare provider should show you how to prepare and measure your dose of SYLATRON, and how to inject yourself before you use SYLATRON for the first time.
- Expect to get “flu-like” symptoms when taking SYLATRON. To
help reduce flu-like symptoms:
- You should take 500 mg to 1,000 mg of acetaminophen 30 minutes before your first dose of SYLATRON.
- Follow your healthcare provider's instructions about taking acetaminophen before future doses of SYLATRON.
- Inject SYLATRON at bedtime to help reduce flu-like symptoms.
- Drink plenty of fluids.
Your healthcare provider should do blood tests before starting and during treatment with SYLATRON.
Your healthcare provider will monitor you while taking SYLATRON. Based on this monitoring, your healthcare provider may:
- Keep your prescribed dose the same;
- Reduce your prescribed dose;
- Tell you to skip a dose or doses; or
- Tell you to stop taking SYLATRON permanently.
What are the possible side effects of SYLATRON?
SYLATRON can cause serious side effects or worsen existing problems, including: See “What is the most important information I should know about SYLATRON?”.
- Heart problems. Signs and symptoms can include:
- fast heart rate or abnormal heart beat
- trouble breathing or chest pain
- Serious eye problems. Symptoms can include:
- decrease in vision
- blurred vision
- Severe or worsening liver problems. Symptoms can
- yellowing of your skin or the white part of your eyes
- swelling of your stomach area (abdomen)
- Thyroid problems. Signs and symptoms can include:
- problems concentrating
- feeling cold or hot all of the time
- weight changes
- High blood sugar (diabetes). Signs and symptoms can
- increased thirst
- urinating more often than normal
- weight loss
- your breath smells like fruit
Call your healthcare provider right away if you have any of these serious side effects.
The most common side effects of SYLATRON include:
- flu-like symptoms, which may include fever, headache, tiredness, muscle or joint aches, chills, nausea, or loss of appetite
- feeling sad or depressed
- redness, swelling, or itching around the injection site
- changes in blood tests measuring how your liver works
These are not all of the possible side effects of SYLATRON. For more information, ask your healthcare provider.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1–800–FDA–1088.
You may also report side effects to Schering Corporation at 1-800-526-4099.
How should I store SYLATRON?
- Store SYLATRON vials in the carton at 59°F to 86°F (15°C to 30°C).
- After mixing, use SYLATRON right away or store it in the refrigerator for no longer than 24 hours at 36°F to 46°F (2°C to 8°C).
- Do not freeze SYLATRON.
Keep SYLATRON and all medicines out of the reach of children.
General information about the safe and effective use of SYLATRON
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use SYLATRON for a condition for which it was not prescribed. Do not give to other people; it may harm them.
This Medication Guide summarizes the most important information about SYLATRON. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider for information about SYLATRON that is written for healthcare professionals.
For more information, go to www.SYLATRON.com or call 1-800-526-4099.
What are the ingredients in SYLATRON?
Active ingredient: peginterferon alfa-2b
Inactive ingredients: dibasic sodium phosphate anhydrous, monobasic sodium phosphate dihydrate, polysorbate 80, sucrose, sterile water for injection is supplied as a diluent.
The Medication Guide has been approved by the U.S. Food and Drug Administration.
Manufactured by: Schering Corporation, a subsidiary of MERCK & CO., INC., Whitehouse Station, NJ 08889, USA. Revised: July 2012
SYLATRON IFU Powder for Injection Instructions for Use
(Peginterferon alfa-2b) For Injection
Be sure that you read, understand and follow these instructions before injecting SYLATRON solution. Your healthcare provider should show you how to prepare, measure, and inject SYLATRON properly before you use it for the first time. Ask your healthcare provider if you have any questions.
Before starting, collect all of the supplies that you will need to use for preparing and injecting SYLATRON. For each injection you will need a SYLATRON vial package that contains:
- 1 vial of SYLATRON powder
- 1 vial of sterile water for injection (diluent)
- 2 single-use disposable syringes (BD Safety Lok syringes with a safety sleeve)
- 2 alcohol swabs
You will also need:
- 1 cotton ball or gauze
- a puncture-proof disposable container to throw away used syringes, needles, and vials.
- Do not re-use or share syringes and needles.
- The vial of mixed SYLATRON should be used right away. Do not mix more than 1 vial of SYLATRON at a time. If you do not use the vial of the prepared solution right away, store it in a refrigerator and use within 24 hours. See the end of these Instructions for Use for information about “How should I store SYLATRON?”
- Make sure you have the right syringe and needle to use with SYLATRON. Your healthcare provider should tell you what syringes and needles to use to inject SYLATRON.
How should I prepare a dose of SYLATRON?
Before you inject SYLATRON, the powder must be mixed with 0.7 mL of the sterile water for injection (diluent) that comes in the SYLATRON vial package.
1. Find a clean, well-lit, flat work surface.
2. Get 1 of your SYLATRON vial packages. Check the date printed on the SYLATRON carton. Make sure that the expiration date has not passed. Do not use your SYLATRON vial packages if the expiration date has passed. The medicine in the SYLATRON vial should look like a white to off-white tablet that is whole, or in pieces, or powdered.
If you have already mixed the SYLATRON solution and stored it in the refrigerator, take it out of the refrigerator before use and allow the solution to come to room temperature.
3. Wash your hands well with soap and water, rinse and towel dry (see Figure 1). Keep your work area, your hands, and injection site clean to decrease the risk of infection.
The disposable syringes have needles that are already attached and cannot be removed. Each syringe has a clear plastic safety sleeve that is pulled over the needle for disposal after use. The safety sleeve should remain tight against the flange while using the syringe and moved over the needle only when ready for disposal. (See Figure 2.)
4. Remove the protective wrapper from one of the syringes provided. Use the syringe for steps 4 through 15. Make sure that the syringe safety sleeve is sitting against the flange. (See Figure 2.)
5. Remove the protective plastic cap from the tops of both the sterile water for injection (diluent) and the SYLATRON vials (see Figure 3). Clean the rubber stopper on the top of both vials with an alcohol swab.
6. Carefully remove the protective cap straight off of the needle to avoid damaging the needle point.
7. Fill the syringe with air by pulling back on the plunger to 0.7 mL. (See Figure 4.)
8. Hold the diluent vial upright. Do not touch the cleaned top of the vial with your hands.
- Push the needle through the center of the rubber stopper of the diluent vial. (See Figure 5.)
- Slowly inject all the air from the syringe into the air space above the diluent in the vial. (See Figure 6.)
9. Turn the vial upside down and make sure the tip of the needle is in the liquid.
10. Withdraw only 0.7 mL of diluent by pulling the plunger back to the 0.7 mL mark on the side of the syringe. (See Figure 7.)
11. With the needle still inserted in the vial, check the syringe for air bubbles.
- If there are any air bubbles, gently tap the syringe with your finger until the air bubbles rise to the top of the syringe.
- Slowly push the plunger up to remove the air bubbles.
- If you push diluent back into the vial, slowly pull back on the plunger to draw the correct amount of diluent back into the syringe.
12. Remove the needle from the vial. (See Figure 8.) Do not let the syringe touch anything.
13. Throw away the diluent vial.
14. Insert the needle through the center of the rubber stopper of the SYLATRON powder vial. Do not touch the cleaned rubber stopper.
- Place the needle tip, at an angle, against the side of the vial. (See Figure 9.)
- Slowly push the plunger down to inject the 0.7 mL diluent. The stream of diluent should run down the side of the vial.
- To prevent bubbles from forming, do not aim the stream of diluent directly on the medicine in the bottom of the vial.
15. Remove the needle from the vial.
- Firmly grasp the safety sleeve and pull it over the exposed needle until you hear a click (see Figure 10). The green stripe on the safety sleeve will completely cover the red stripe on the needle. Discard the syringe, needle, and vial in the puncture-proof container.
16. Gently swirl the vial in a gentle circular motion, until the SYLATRON is completely dissolved (mixed together). (See Figure 11.)
- Do not shake the vial. If any powder remains undissolved in the vial, gently turn the vial upside down until all of the powder is dissolved.
- The solution may look cloudy or bubbly for a few minutes. If air bubbles form, wait until the solution settles and all bubbles rise to the top.
17. After the SYLATRON completely dissolves, the solution should be clear, colorless and without particles. It is normal to see a ring of foam or bubbles on the surface.
- Do not use the mixed solution if you see particles in it, or it is not clear and colorless. Throw away the syringe and needle in the puncture-proof container. (See the section “How should I dispose of the used syringes, needles, and vials?”.) Then, repeat steps 1 through 17 with a new vial of SYLATRON and diluent to prepare a new syringe.
18. After the SYLATRON powder completely dissolves, clean the rubber stopper again with an alcohol swab before you withdraw your dose.
19. Unwrap the second syringe provided. You will use it to give yourself the injection.
- Carefully remove the protective cap from the needle. Fill the syringe with air by pulling the plunger to the number on the side of the syringe (mL) that matches your prescribed dose. (See Figure 12.)
- Hold the SYLATRON vial upright. Do not touch the cleaned top of the vial with your hands. (See Figure 13.)
- Insert the needle into the vial containing the SYLATRON solution. Inject the air into the center of the vial. (See Figure 14.)
20. Turn the SYLATRON vial upside down. Be sure the tip of the needle is in the SYLATRON solution.
- Hold the vial and syringe with one hand. Be sure the tip of the needle is in the SYLATRON solution. With the other hand, slowly pull the plunger back to fill the syringe with the exact amount of SYLATRON into the syringe your healthcare provider told you to use. (See Figure 15.)
21. Check for air bubbles in the syringe. If you see any air bubbles, hold the syringe with the needle pointing up. Gently tap the syringe until the air bubbles rise. Then, slowly push the plunger up to remove any air bubbles. If you push solution into the vial, slowly pull back on the plunger again to draw the correct amount of SYLATRON back into the syringe. When you are ready to inject the medicine, remove the needle from the vial. (See Figure 16.)
How should I choose a site for injection?
The best sites for giving yourself an injection are those areas with a layer of fat between the skin and muscle, like your thigh, the outer surface of your upper arm, and abdomen (see Figure 17). Do not inject yourself in the area near your navel or waistline. If you are very thin, you should only use the thigh or outer surface of the arm for injection.
You should use a different site each time you inject SYLATRON to help avoid soreness at any one site. Do not inject SYLATRON solution into an area where the skin is irritated, red, bruised, infected or has scars, stretch marks, or lumps.
How should I inject a dose of SYLATRON?
22. Clean the skin where the injection is to be given with an alcohol swab. Wait for the area to dry.
- Make sure the safety sleeve of the syringe is pushed firmly against the syringe flange so that the needle is fully exposed. (See Figure 2.)
23. With one hand, pinch a fold of skin. With your other hand, pick up the syringe and hold it like a pencil.
- Insert the needle into the pinched skin at a 45- to 90-degree angle with a quick dart-like motion (see Figure 18).
- After the needle is inserted, remove the hand that you used to pinch your skin. Use it to hold the syringe barrel.
- Pull the plunger of the syringe back very slightly.
- If no blood is present in the syringe, inject the medicine by gently pressing the plunger all the way down the syringe barrel, until the syringe is empty.
- If blood comes into the syringe, the needle
has entered a blood vessel. Do not inject.
- Withdraw the needle and throw away the syringe and needle in the puncture-proof container. (See step 24 and the disposal steps below.)
- Then, repeat steps 1 through 23 with a new vial of SYLATRON and diluent to prepare a new syringe, and inject the medicine at a new site.
24. When the syringe is empty, pull the needle out of the skin.
- Place a cotton ball or gauze over the injection site and press for several seconds. Do not massage the injection site.
- If there is bleeding, cover it with a bandage.
25. After injecting your dose:
- Firmly grasp the safety sleeve and pull it over the exposed needle until you hear a click, and the green stripe on the safety sleeve covers the red stripe on the needle (see Figure 19).
26. Throw away the used syringe, needle, and SYLATRON vial(s) in the puncture-proof disposable container. (See “How should I dispose of the used syringes, needles, and vials?”.)
How should I dispose of the used syringes, needles, and vials?
- Throw away used syringes, needles, and vials in a puncture-proof container, sharps container, or a hard container like a metal can with a lid. Always place needles facing down. Do not use glass or clear plastic containers. Always keep the puncture-proof container out of the reach of children.
- Do not throw away used needles, syringes, or the puncture-proof container in household trash and do not recycle them.
- Check with your healthcare provider for instructions about the right way to throw away used needles and syringes. There may be local or state laws about how to throw away used needles and syringes. Always follow the instructions of your healthcare provider.
How should I store SYLATRON?
- Before mixing, store SYLATRON vials at 59°F to 86°F (15°C to 30°C).
- After mixing, use SYLATRON right away or store it in the refrigerator for up to 24 hours between 36°F to 46°F (2°C to 8°C). Throw away any mixed SYLATRON that is not used within 24 hours.
- Do not freeze SYLATRON.
- Keep SYLATRON away from heat.
- Keep SYLATRON and all medicines out of the reach of children.
These Instructions for Use have been approved by the U.S. Food and Drug Administration.
Last reviewed on RxList: 7/13/2012
This monograph has been modified to include the generic and brand name in many instances.
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