Patient Medication Information: uses, side effects, how to take - Vantas
ABOUT THIS MEDICATION
What the medication is used for:
Your doctor has prescribed Vantas® as part of your
treatment for prostate cancer.
What it does:
Vantas® is a drug delivery system that contains the medicine histrelin acetate. It looks like a small, thin flexible tube. Your doctor places Vantas® under the skin of your upper, inner arm so that it can deliver the medication to your body continuously for 12 months.
Vantas® is a Luteinizing Hormone-Releasing Hormone (LHRH) Analogue also known as a GnRH agonist. It works by reducing testosterone produced by the testicles. This lowers the amount of testosterone in the body. Testosterone appears to be needed by prostate cancer cells. By lowering the amount of testosterone in the body, Vantas ® may help relieve the pain, urinary problems, and other symptoms of prostate cancer. You may notice an improvement in your symptoms approximately 1 month after receiving Vantas ®. Vantas® is not a cure for prostate cancer.
When it should not be used:
Do not use Vantas® if you are allergic or hypersensitive to the histrelin acetate, to any ingredients in the formulation or component of the implant or to drugs called LHRH agonists or GnRH agonists (see: What the non medicinal ingredients are).
Do not use Vantas® for women who are or may become pregnant, for nursing mothers and for women in general.
In pregnant women, Vantas® may cause harm to the baby or a miscarriage (losing the baby).
Vantas® was not studied in children and should not be used in children under 18 years of age.
What the medicinal ingredient is:
Histrelin acetate 50 mg (delivered as approximately 50 µg histrelin/day)
What the nonmedicinal ingredients are:
Sodium Chloride Solution
Stearic Acid
Delivered within a hydrophilic polymer implant.
What dosage forms it comes in:
Vantas® is a subdermal implant. It looks like a small, thin flexible tube.
WARNINGS AND PRECAUTIONS
BEFORE you use Vantas®, talk to your doctor or pharmacist if:
- You have any allergies to this drug, or its ingredients, or to components of the implant
- You have a strong family history of osteoporosis, have low bone density (BMD), or taking any medication that causes thinning of the bones. Vantas® may increase your risk of osteoporosis and bone fractures,
- You have or have had liver disease
- You have a history of heart disease or disorders, or have a genetic heart condition called “long QT syndrome”
- You have high blood sugar (diabetes). Vantas® may affect your blood sugar and you may need to test your blood sugar more frequently while receiving treatment with Vantas.
- You have low red blood cell counts, Vantas® may cause a decrease in red blood cells (anemia)
INTERACTIONS WITH THIS MEDICATION
Before your treatment with Vantas®, tell your doctor about all the medicines you take, including prescription and non-prescription drugs, vitamins and herbal remedies. In particular, if you are taking drugs for abnormal heart rhythms, psychosis, nausea resulting from chemotherapy, asthma, antibiotics, or antifungal
Serious Warnings and Precautions: VANTAS should be prescribed by a doctor experienced with this type of drugs.
VANTAS may cause:
- worsening of symptoms of prostate cancer at the beginning of the treatment
- bone thinning (osteoporosis)
drugs. During your treatment with Vantas® do not start taking a new medicine before checking with your doctor or pharmacist.
It is not known if Vantas® and other medicines can affect each other.
PROPER USE OF THIS MEDICATION
The recommended dose of Vantas® is one implant for 12 months.
Vantas® is placed under the skin of your upper, inner arm. Your doctor will numb your arm, make a small incision (cut), and then place Vantas® under the skin. The cut will be closed with special surgical tape and covered with a bandage. Keep your arm clean and dry and do not swim or bathe for 24 hours. The pressure bandage can be removed at that time. You should not remove the surgical strips they will fall off on their own in several days. Avoid heavy lifting and exercise for 7 days. Avoid bumping the site for a few days. After the cut has healed, you can go back to your normal activities.
Remember to see your doctor for routine checks on your condition and to ensure that Vantas® is present and functioning in your body.
Your doctor will do blood tests to check on your response to treatment with Vantas®. For example, your doctor may check your prostate specific antigen (PSA) or testosterone levels.
Vantas® must be removed after 12 months of therapy. Your doctor may insert a new Vantas® to continue therapy.
Overdose:
Given the design and delivery method of the drug, it is unlikely that an overdose may occur.
In case of drug overdose, contact a health care
practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
Missed Dose:
Contact your physician or pharmacist as soon as you realise that you have missed your scheduled appointment.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Vantas® may cause an increase in the blood levels of testosterone during the first week after it is inserted. As a result your symptoms may get worse for a few weeks. You may also get new symptoms.
You may also experience palpitations (pounding heart beat), abdominal discomfort, nausea, muscle pain, bone pain, joint pain, and/or urination problems (difficulty passing urine or having to go the bathroom too often).
Bruising and redness may occur. These reactions, if they occur at all, are usually mild and heal without treatment within 2 weeks. If they do not heal or if you have unusual bleeding, contact your doctor.
Vantas® can be expelled from your body through the original incision site. This occurs infrequently. You may notice the system being expelled, or rarely, the system may be expelled without you noticing it. If you believe Vantas® has been expelled from your body contact your doctor.
Vantas® can cause a loss in bone mineral density. This can lead to thinning of the bones (osteoporosis).
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||||
| Talk with your doctor or pharmacist | Call your doctor right away | |||
| Symptom / effect | Only if severe | In all cases | ||
Very Common | Hot flashes | ✓ | ||
| Common | Tiredness Increase in Weight Implant site reaction Erectile dysfunction (impotence) Enlargement of breasts Testicles become smaller Trouble Sleeping Lowered libido Constipation Headache Trouble Urinating | ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ | ✓ ✓ | |
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||||
Talk with your doctor or pharmacist | Call your doctor right away | |||
| Symptom / effect | Only if severe | In all cases | ||
| Uncommon | Bone pain Weakness or loss of feeling in legs Blood in Urine Cannot Urinate | ✓ ✓ ✓ ✓ | ||
These side effects can happen throughout the entire time of your treatment, not only at the beginning.
This is not a complete list of side effects. For any unexpected effects while taking Vantas®, contact your doctor or pharmacist.
HOW TO STORE IT
Store under refrigeration (2 to 8 °C). Protect from freezing. Protect from light.
Keep in a safe place out of reach of children.
REPORTING SUSPECTED SIDE EFFECTS You can report any suspected adverse reactions 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:
- Fax toll-free to 1-866-678-6789, or
Mail to : Canada Vigilance Program Health Canada
Postal Locator 0701D Ottawa, Ontario K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ 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 found by contacting the sponsor, Paladin Labs Inc., at:
1-888-550-6060