Supprelin LA

Last updated on RxList: 8/14/2019
Supprelin LA Side Effects Center

Last reviewed on RxList 8/14/2019

Supprelin LA (histrelin acetate) is a man-made form of gonadotropin releasing hormone (GnRH) 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. Common side effects of Supprelin LA include:

  • irritation at the implant site (such as bruising, pain, redness),
  • mood swings,
  • headache,
  • nosebleeds,
  • tiredness,
  • weight changes,
  • constipation,
  • night sweats,
  • feeling hot or cold,
  • impotence,
  • loss of interest in sex,
  • trouble having an orgasm, or
  • pain or swelling in your testicles.

In girls using this medication for early puberty, side effects of Supprelin LA include breast swelling or tenderness, abnormal vaginal bleeding, menstrual pain, or heavy menstrual bleeding.

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.

Supprelin LA Consumer Information

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

Call your doctor at once if you have:

  • bone pain, numbness or weakness in your legs or feet;
  • painful or difficult urination, blood in your urine;
  • a seizure; or
  • mental problems--crying spells, anger, aggression, feeling restless or irritable.

Common side effects may include:

  • constipation;
  • urination problems;
  • breast swelling;
  • hot flashes;
  • feeling tired;
  • erectile dysfunction (impotence), decreased testicle size; or
  • pain, redness, bruising, swelling, or skin irritation where the implant was inserted.

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)

Supprelin LA Professional Information

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)

© Supprelin LA Patient Information is supplied by Cerner Multum, Inc. and Supprelin LA Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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