Proudly Delivering
Life-Changing Treatments
Proudly Delivering
Life-Changing Treatments
Tolmar delivers specialized, long-acting injectables in the areas of urology, oncology, and endocrinology. We’re passionately committed to servicing this reputable treatment portfolio to prioritize ease and comfort for patients all over the world.
Treatments
Fensolvi® Treatment for CPP
About Fensolvi®
FENSOLVI® (leuprolide acetate for injectable suspension) is the first and only subcutaneous injection gonadotropin releasing hormone therapy (GnRH) used to delay puberty for children with CPP. It is used for patients older than 2 years of age and younger than 8 years of age for boys and 9 years of age for girls.
FENSOLVI® treatments occur just twice a year with 6-month dosing, helping children with CPP limit doctor’s visits. These treatments are taken for as long as a child needs to delay their puberty.
Important Safety Information
To learn more about FENSOLVI, please visit the official FENSOLVI website.
IMPORTANT SAFETY INFORMATION
FENSOLVI is a type of medicine known as a gonadotropin releasing hormone (GnRH) agonist. It is used to treat central precocious puberty (CPP) in children 2 years of age and older and is administered as an injection under the skin (subcutaneously) by your child’s healthcare provider.
FENSOLVI should not be given to children:
- Who are sensitive to GnRH, GnRH agonists or any of the ingredients in FENSOLVI (your child’s doctor can help you know this)
- Call your child’s doctor or get emergency medical help right away if your child has any symptoms of a serious allergic reaction
- Who are pregnant. FENSOLVI can cause birth defects or loss of the baby
During the first few weeks of treatment, an increase in signs and symptoms of puberty, including vaginal bleeding in girls, may occur.
Some children may have emotional changes with FENSOLVI, including crying, irritability, impatience, anger, or aggression. Call your child’s doctor right away if your child has any new or worsening emotional symptoms while taking FENSOLVI.
There have been reports of convulsions (uncontrolled movements due to rapid contraction and relaxation of muscles) in children taking GnRH agonists. Convulsions may occur in children who have not had them before. If your child has a convulsion, call your child’s doctor, or get emergency help right away.
Idiopathic Intracranial Hypertension (unexplained elevated pressure in the brain) has been reported in pediatric patients receiving GnRH agonists. Call your child’s doctor right away if your child has headaches and/or vision issues.
The most common side effects seen in studies with FENSOLVI were injection site pain/redness, colds/sore throat, fever, headache, cough, stomach pain, nausea, constipation, vomiting, wheezing, wet cough and hot flush. Tell your child’s doctor about any side effects.
These are not all the possible side effects of FENSOLVI. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Please see Full Prescribing Information for additional Important Safety Information.
Eligard® Treatment for Prostate Cancer
About Eligard®
ELIGARD® (leuprolide acetate) for injectable suspension is a prescription prostate cancer therapy that suppresses androgen hormones. ELIGARD is used for advanced prostate cancer management.
ELIGARD treatments are designed to be delivered over a 1-, 3-, 4-, or 6-month therapeutic period—the timing is completely flexible based on patient needs. The strength of the dosage depends on this timing:
- 1 month: ELIGARD 7.5 mg
- 4 months: ELIGARD 30 mg
- 3 months: ELIGARD 22.5 mg
- 6 months: ELIGARD 45 mg
Important Safety Information
To learn more about ELIGARD, please visit the official ELIGARD website.
Important Safety Information for ELIGARD (leuprolide acetate) for injectable suspension
ELIGARD® is used for the treatment of advanced prostate cancer. ELIGARD is a prescription medication that must be administered by a health care professional.
- ELIGARD should not be used by anyone who is allergic to any of the ingredients in ELIGARD or to any similar drugs.
- ELIGARD causes an increase in testosterone during the first few weeks of therapy and some men may experience new or worsening symptoms of prostate cancer e.g., bone pain, urinary symptoms, or nerve problems such as numbness, during this period. If your cancer has spread to the urinary tract or spine, urinary blockage or pressure on the spine that can lead to paralysis may occur. Your doctor will discuss with you the benefits and risks of taking ELIGARD.
- Increased risk of heart attack, sudden death due to heart problems and stroke have also been reported in men taking ELIGARD. ELIGARD may also affect electrical activity in the heart that can cause an irregular heartbeat. Your doctor will monitor you for heart conditions.
- Elevated blood sugar and an increased risk of developing diabetes have been reported in men receiving ELIGARD. Your doctor will monitor blood sugar levels.
- Convulsions have been observed in patients taking leuprolide acetate, including patients who have a history of seizures, epilepsy, or brain disorders (related to blood vessels, nerves, or tumors), and in those taking medications associated with convulsions. Convulsions have also been reported in patients without any of these conditions.
- ELIGARD may cause fetal harm when administered to a pregnant woman. Expected hormonal changes that occur with ELIGARD treatment increase the risk for pregnancy loss.
- ELIGARD may impair fertility in males of reproductive potential.
The most common injection site reactions are transient burning and stinging, pain, bruising, and redness. The most common side effects include hot flashes/sweats, fatigue, weakness, muscle pain, dizziness, clamminess, testicular shrinkage, decreased erections and enlargement of breasts.Other side effects, including thinning of bones that may lead to fracture, and rare but serious problems with the pituitary gland in the brain, have been reported with ELIGARD.
Call your doctor for medical advice about side effects. You may report side effects to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please see Full Prescribing Information for additional Important Safety Information.
Jatenzo® Treatment for Testosterone Replacement
About Jatenzo®
JATENZO® is an FDA-approved prescription drug for men with low or no testosterone due to preexisting medical conditions. It is currently the most prescribed softgel treatment for testosterone replacement.
A twice daily pill that’s taken with food and water, JATENZO delivers testosterone to the bloodstream, helping the body feel balanced again. JATENZO dosages are also adjustable, allowing healthcare providers to work with patients to determine a correct dosage.
Important Safety Information
Important Safety Information about Jatenzo
What is JATENZO?
JATENZO® (testosterone undecanoate) capsules are prescribed to adult men for testosterone replacement therapy when they have a deficiency or absence of their natural testosterone due to structural or genetic causes.
Safety and efficacy of JATENZO in boys less than 18 years old have not been established. JATENZO is a controlled substance, CIII, due to risk for physical and psychological dependence and abuse.
What important safety information is there for JATENZO?
- JATENZO might raise your blood pressure, which could cause serious heart problems like heart attacks, strokes, or even death related to heart conditions.
- Before taking JATENZO, your doctor should check your blood pressure and consider your risk for heart problems. Your doctor should also periodically monitor new-onset and pre-existing high blood pressure.
- Due to this risk, JATENZO should only be used for treatment of men who have a deficiency or absence of natural testosterone due to structural or genetic causes.
Who should not take JATENZO?
JATENZO should not be used in men with breast cancer or known or suspected prostate cancer, in women who are pregnant, in men who are over-sensitive to JATENZO or its ingredients, or in men with low testosterone that is not associated with structural or genetic factors
What side effects should I be aware of before starting JATENZO?
Increase blood pressure. JATENZO can increase blood pressure, which can increase the risk of serious heart problems, especially in with established risk factors for heart disease.
Elevated red blood cell counts. This may increase the risk of blood clots, strokes, and heart attacks.
Benign prostatic hyperplasia (BPH). If you have been previously diagnosed with BPH, signs and symptoms may worsen.
Prostate cancer. Patients taking testosterone may be at increased risk for prostate cancer.
Blood clots. Blood clots in the legs that may travel to the lungs have been reported in patients using testosterone replacement products.
Abuse. Testosterone has been subject to abuse, typically at doses higher than recommended. Testosterone abuse can lead to serious cardiovascular and psychiatric side effects, including depression and suicidal ideas.
Low sperm count. Large doses of testosterone products may suppress sperm production.
Liver problems. JATENZO is not known to cause liver side effects; however, report any signs of liver problems to your doctor.
Swelling of your ankles, feet, or body (edema).
Enlarged or painful breasts.
Sleep apnea. Testosterone may worsen sleep apnea, especially with risk factors such as excess body fat or chronic lung conditions.
Changes in lipid levels. Lipid changes may require dose adjustment of your cholesterol medication or stopping testosterone treatment.
Changes in mood. Talk to your healthcare provider if you have changes in mood or behavior including, new or worsening depression, or suicidal thoughts.
What are the most common side effects with JATENZO?
The most common side effects of JATENZO are increased red blood cell count, diarrhea, indigestion, burping, swelling of the leg or foot, nausea, enlarged prostate gland, high blood pressure, and headache.
What medications should I tell my doctor that I am taking before starting JATENZO?
Tell your healthcare provider about all medications that you are taking prior to starting JATENZO, including prescription, over the counter medicines, vitamins, and supplements. Ensure that you notify your provider if you take insulin, blood-thinning medications, corticosteroids, or common pain or cold medicines.
Please see full Prescribing Information, including boxed warning on increases in blood pressure, and Medication Guide.
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