Patient Medication Information: uses, side effects, how to take - Winrho Sdf (Aptevo Biotherapeutics)
ABOUT THIS MEDICATION
What the medication is used for:
Protection (prophylaxis) against the development of harmful antibodies in Rh-negative women exposed to Rh-positive blood. This exposure can occur in an Rh-negative woman:
o Upon receipt of an Rh-positive blood transfusion
o During pregnancy or after delivery if the baby is Rh-positive or the Rh status is unknown.
Treatment of Immune Thrombocytopenic Purpura (ITP)
o In children with chronic or acute ITP
o In adults with chronic ITP
o In children and adults with ITP secondary to HIV infection
What it does:
Protection (prophylaxis) against the development of harmful antibodies in Rh-negative women exposed to Rh-positive blood.
Pregnant women often have different blood groups from their babies. This is normal and usually not a problem. However, in some cases, these blood groups differ in an important way, which is the presence or absence of a particular protein on the outside of the red blood cell. If you have this protein, you are “Rh positive”. If you do not have this protein, you are “Rh negative”.
Sometimes during pregnancy and delivery, a small amount of the baby’s blood can cross the placenta and enter the mother’s blood stream. This can also happen in events such as a miscarriage, abdominal injury, abortion and amniocentesis. If this transfer of blood occurs from an Rh positive fetus to an Rh negative mother, the mother’s immune system will see the baby’s blood as “foreign” and will produce antibodies which destroy the baby’s blood cells. In the first pregnancy, most of these antibodies will remain in the mother’s circulation and the baby is usually not significantly affected. During subsequent pregnancies, however, a problem may occur if the new baby is Rh positive and if there is another transfer of blood across the placenta. The mother’s immune system has a good memory. It can rapidly produce the same antibodies again, and they can re-cross the placenta in large numbers and start to destroy the new baby’s own blood before birth, causing a number of serious complications.
WinRho® SDF is an injection of antibodies administered with every pregnancy, when the mother is known to be Rh-negative. It works in your bloodstream to destroy any circulating blood cells from your baby before your immune system has a chance to make its own antibodies. Your baby is not affected by this injection.
Injections may also be given in connection with abortion, miscarriage or amniocentesis or because of mismatched blood transfusion. As a result of the WinRho® SDF injection, your immune system never makes its own antibodies to your baby’s Rh positive red blood cells, so you and your baby are protected.
Treatment of ITP
ITP is a bleeding disorder caused by an abnormally low level of platelets. Platelets are found in the bloodstream and are needed for blood to clot properly. When blood does not clot properly, there is a tendency to bruise and bleed easily. ITP is a disorder of the immune system. Usually, the body will manufacture antibodies which coat disease-causing organisms, aiding their removal by the spleen. This process helps the immune system fight infection in the body. In ITP, the body mistakenly produces antibodies against its own platelets. When these antibodies coat the platelets, it results in their rapid and premature destruction by the spleen. ITP can affect adults or children; it can occur without warning and for no apparent reason, or it can occur as a result of a primary illness or infection. There is no evidence to suggest that ITP is inherited or related to personal habits or diet. It cannot be passed to other people like the common cold.
WinRho® SDF contains a concentration of antibodies which specifically bind to Rh positive red blood cells. When administered to an Rh positive patient, it is thought that WinRho® SDF coats the Rh positive red cells, causing their destruction by the spleen, thereby preventing the destruction of platelets. This results in increased levels of circulating platelets and an alleviation of the symptoms of ITP.
When it should not be used:
- WinRho® SDF must not be used if you are hypersensitive (allergic) to human immunoglobulin or to any other ingredients of WinRho® SDF.
- WinRho® SDF should not be used for Rh prevention if you are Rh-positive or if you are Rh-negative but have been previously Rh immunized.
- WinRho® SDF should not be used to treat ITP if you are Rh-negative, or if you have had your spleen surgically removed.
- WinRho® SDF should not be used to treat ITP if you have Leukemia, lymphoma or active viral infections such as Hepatitis C or Epstein Barr Virus (EBV).
- WinRho® SDF should not be used to treat ITP if you have a condition that causes red blood cell destruction (i.e. haemolytic anemia).
- WinRho SDF should not be used to treat ITP if you are elderly with conditions that could increase the risk of developing acute haemolytic reactions (AHR) or its complications.
- WinRho® SDF should not be used to treat patients who are IgA deficient.
What the medicinal ingredient is:
Rho (D) Immune Globulin (Human)
What the important nonmedicinal ingredients are:
Lyophilized (Freeze-dried) Formulation
Human plasma protein
Sodium Chloride
Glycine
Polysorbate 80
Liquid Formulation
Human plasma protein
Maltose
Polysorbate 80
WinRho® SDF may contain trace amounts of tri-n-butyl phosphate and Triton X-100.
What dosage forms it comes in:
Lyophilized: 600 IU (120 µg), 1500 IU (300 µg),
5000 IU (1000 µg)
Liquid: 600 IU (120 µg), 1500 IU (300 µg),
2500 IU (500 µg), 5000 IU (1000 µg),
15 000 IU (3000 µg)
WARNINGS AND PRECAUTIONS
Serious Warnings and Precautions
|
BEFORE you use WinRho® SDF talk to your doctor or pharmacist if:
- You have experienced allergic reactions to blood products in the past
- You have a known IgA deficiency
- You have recently received any vaccinations
- You are allergic to WinRho® SDF or any of its ingredients or components of the container
You are taking any other medications including over the counter medications and herbal products.
- You are over 65 years of age and have other co-existing medical conditions such as those related to your heart, lungs, liver or kidneys.
INTERACTIONS WITH THIS MEDICATION
Drugs that may interact with WinRho® SDF have not been established.
Immune globulins like WinRho® SDF may reduce the effectiveness of certain live virus vaccines such as measles, rubella (i.e. German measles), mumps and varicella (i.e. chickenpox). Talk to your doctor if you have been recently vaccinated.
PROPER USE OF THIS MEDICATION
Usual dose:
Protection against the development of harmful antibodies in Rh-negative women exposed to Rh-positive blood
Pregnancy and other obstetric conditions:
A dose of 1,500 IU (300 µg) of WinRho® SDF is given at 28 weeks of pregnancy. A 600 IU (120 µg) dose of WinRho® SDF is given after delivery of an Rh-positive baby.
A 1500 IU (1300 µg) dose of WinRho® SDF is given within 72 hours of obstetric complications (e.g., miscarriage, abortion, threatened abortion, ectopic pregnancy or hydatidiform mole, transplacental hemorrhage resulting from antepartum hemorrhage).
A dose of 1,500 IU (300 µg) of WinRho® SDF is given within 72 hours of invasive procedures during pregnancy (e.g., amniocentesis, chorionic biopsy) or obstetric manipulative procedures (e.g., external version, abdominal trauma). In case of threatened abortion, WinRho® SDF is given as soon as possible.
Transfusion
If you are exposed to Rh-positive blood or red blood cells, WinRho® SDF will be administered by your doctor to prevent development of harmful antibodies. The usual dose of WinRho® SDFis between 45 IU/mL and 120 IU/mL (9 µg/mL and 24 µg/mL).
Treatment of ITP
WinRho® SDF is given at an initial dose of 250 IU/kg (50 µg/kg). If you need additional therapy to increase your platelet counts, then a dose of 125 to 300 IU/kg (25 to 60 µg/kg) is given.
Overdose:
In the treatment of ITP patients, WinRho® SDF overdoses have been reported to result in more chills, fever and headaches in patients as well as greater decreases in red blood cell measures (i.e. hemolysis with urine discoloration). One of these cases resulted in death. Patients should discuss with their physician the WinRho® SDF dose they are receiving and report the side effects to the physician without delay.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
GENERAL
If you have been told that you have an IgA deficiency, you have a greater risk of having an allergic reaction to WinRho® SDF. While there is only a rare chance that you may experience a sudden, severe allergic reaction after receiving WinRho® SDF, you should be aware of the symptoms of an allergic reaction. These are:
- hives,
- rash,
- chest tightness,
- wheezing,
- shortness of breath,
- feeling light-headed or dizzy when you stand (this could mean a drop in blood pressure).
If you experience any of these symptoms, call your doctor immediately.
Protection against the development of harmful antibodies in Rh-negative women exposed to Rh-positive blood
Reactions to WinRho® SDF are rare in Rh-negative individuals. Discomfort or slight swelling at the injection site and slight elevation in temperature have been reported in a small number of cases.
Treatment of ITP
Most WinRho® SDF patients do not experience any drug related adverse effects. Among the few who do, the most commonly reported effects include headache, chills and fever. Rare side effects such as vomiting, nausea, low blood pressure, an increase in your heartbeat, joint pain, anemia (decrease in red blood cells), intravascular hemolysis (destruction of red blood cells), back pain, shaking chills, hemoglobinuria (brownish discolouration of urine), and acute renal insufficiency (kidney failure) may also occur. If you experience any of the following symptoms after receiving WinRho® SDF, you should call your doctor immediately:
- back pain,
- discolored or darkened urine,
- decreased urine production,
- jaundice,
- swelling,
- shortness of breath.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||||
|---|---|---|---|---|
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and call your doctor or pharmacist | ||
| Only if severe | In all cases | |||
| Common | Discomfort or swelling at injection site, elevation in temperature | ✓ | ||
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||||
|---|---|---|---|---|
| Uncommon | Allergic reaction Back pain, discoloured urine, darkened urine, decreased urine output, jaundice, swelling, shortness of breath | ✓ ✓ | ✓ ✓ | |
This is not a complete list of side effects. For any unexpected effects while taking WinRho® SDF, contact your doctor or pharmacist.
HOW TO STORE IT
Store WinRho® SDF under refrigeration.
Do not freeze.
Do not use after expiration date.
REPORTING SUSPECTED SIDE EFFECTS
You can report any suspected adverse reaction associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways: Report online at www.healthcanada.gc.ca/medeffect Call toll-free at 1-866-234-2345 Complete a Canada Vigilance Reporting Form and:
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at www.healthcanada.gc.ca/medeffect . NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice. |
MORE INFORMATION
This document plus the full product monograph, prepared for health professionals can be obtained by contacting Aptevo BioTherapeutics at 1-844-859-6675.
PLANOVA® is a registered trademark of Asahi Kasei Medical Co., Ltd. TRITON® is a registered trademark of Union Carbide Corporation.
WinRho® SDF is a registered trademark of Aptevo
BioTherapeutics LLC