Supprelin LA

Supprelin LA Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Supprelin LA (histrelin acetate) is used to treat precocious puberty in both male and female children. The Vantas brand of histrelin is used to treat symptoms of prostate cancer in men and should not be used in women or children. It is a man-made form of gonadotropin releasing hormone (GnRH). Common side effects include irritation at the implant site (such as bruising, pain, redness), mood swings, or headache. In girls using this medication for early puberty, breast tenderness or abnormal vaginal bleeding may occur.

The recommended dose of Supprelin LA is one implant every 12 months. Each implant contains 50 mg histrelin acetate. The implant is inserted subcutaneously in the inner aspect of the upper arm and provides continuous release of histrelin acetate (65 mcg/day) for 12 months of hormonal therapy. Other drugs may interact with Supprelin LA. Tell your doctor all medications and supplements you use. Supprelin LA is not approved for use in women. It must not be used during pregnancy. It may harm a fetus. It is unknown if this drug passes into breast milk or if it could harm a nursing baby. Consult your doctor before breastfeeding.

Our Supprelin LA (histrelin acetate) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Supprelin LA in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • fever, chills, body aches, flu symptoms;
  • swelling, redness, oozing, or other signs of infection around the implant;
  • severe bone pain, severe numbness or tingling in your legs or feet;
  • blood in your urine, pain when you urinate;
  • painful or difficult urination, urinating less than usual or not at all;
  • upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • muscle weakness, problems with balance or coordination;
  • loss of movement in any part of your body, loss of bladder or bowel control;
  • increased thirst or urination, excessive hunger, fruity breath odor;
  • sudden numbness or weakness, sudden severe headache, confusion, problems with vision or speech; or
  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling.

Less serious side effects may include:

  • headache;
  • nosebleeds;
  • mood changes, tired feeling;
  • weight gain or loss;
  • menstrual pain, heavy menstrual bleeding;
  • constipation;
  • breast swelling or tenderness;
  • night sweats, feeling hot or cold;
  • impotence, loss of interest in sex, trouble having an orgasm; or
  • pain or swelling in your testicles.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Supprelin LA (Histrelin Acetate Subcutaneous Implant) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Supprelin LA Overview - Patient Information: Side Effects

SIDE EFFECTS: Irritation at the implant site (such as bruising, pain, redness), mood swings, or headache may occur. In men using this medication for prostate cancer, hot flashes (flushing), increased sweating, night sweats, tiredness, swelling of the ankles/feet, or constipation may occur. In girls using this medication for early puberty, breast tenderness or abnormal vaginal bleeding may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Infrequently, breast tenderness/swelling may occur in men and boys as a result of lowered testosterone levels. Shrinking of the testicles and reduced sexual interest/ability may also occur in men. Talk to your doctor if these effects occur.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

If you are a man using this medication for prostate cancer, tell your doctor immediately if any of these unlikely but serious side effects occur: new/worsening bone pain, easily broken bones, increased thirst/urination.

Get medical help right away if any of these rare but serious side effects occur: chest/jaw/left arm pain, irregular heartbeat, weakness on one side of the body, slurred speech.

Rarely, a very serious problem with the pituitary gland (pituitary apoplexy) has been reported with similar drugs, usually in the first 2 weeks after starting treatment. Seek immediate medical attention if any of these very serious side effects occur: sudden severe headache, sudden severe mental/mood changes (e.g., severe confusion, difficulty concentrating), vision changes, severe vomiting, fainting.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Supprelin LA (Histrelin Acetate Subcutaneous Implant)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Supprelin LA FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Overall Adverse Reaction Profile

The most common adverse reactions with SUPPRELIN LA involved the implant site. Local reactions after implant insertion include bruising, pain, soreness, erythema and swelling. During the early phase of therapy, gonadotropins and sex steroids rise above baseline because of the natural stimulatory effect of the drug. Therefore, an increase in clinical signs and symptoms may be observed [see WARNINGS AND PRECAUTIONS].

Adverse Reactions in Clinical Trials

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety of SUPPRELIN LA in children with CPP was evaluated in two single-arm clinical trials conducted in a total of 47 patients (44 females and 3 males) over a period of time ranging from 9 to 18 months. The most commonly reported adverse reaction was implant site reaction, which was reported by 24 of 47 (51.1%) patients. Implant site reaction includes discomfort, bruising, soreness, pain, tingling, itching, implant area protrusion and swelling. Two subjects experienced a serious adverse reaction: 1 subject who coincidentally had Stargardt's Disease experienced amblyopia and 1 subject had a benign pituitary tumor (pituitary adenoma). One subject discontinued the study due to an adverse reaction of infection at the implant site. There were no clinically meaningful findings in standard clinical hematology and chemistry tests and/or in vital signs. The incidence of implantation adverse events reported by more than 2 patients are summarized in Table 1.

Table 1: Incidence of implantation adverse reactions reported by ≥ 2 patients treated with SUPPRELIN LA in both clinical trials

Adverse Reactions N=47
N (%)
Implant site reaction 24 (51.1)
Keloid scar 3 (6.4)
Scar 3 (6.4)
Suture related complication 3 (6.4)
Application site pain 2 (4.3)
Post procedural pain 2 (4.3)

The following adverse reactions were reported as possibly related or related in 1 patient each: wound infection, breast tenderness, dysmenorrhea, epistaxis, erythema, feeling cold, gynecomastia, headache, menorrhagia, migraine, mood swings, pituitary tumor benign, pruritus, weight increased, disease progression and influenzalike illness. The adverse reaction metrorrhagia was reported as possibly related or related in 2 patients.

Post-marketing Experience

The following adverse reactions have been identified during post approval use of SUPPRELIN LA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

General Disorders and Administration Site Conditions: implant breakage

Nervous System Disorders: seizures

Read the entire FDA prescribing information for Supprelin LA (Histrelin Acetate Subcutaneous Implant) »

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Supprelin LA - User Reviews

Supprelin LA User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Supprelin LA sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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