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Jalyn

  • Generic Name: dutasteride and tamsulosin hydrochloride capsules
  • Brand Name: Jalyn
  • Drug Class: Urologics, Other

Jalyn (Dutasteride and Tamsulosin Hydrochloride Capsules) side effects drug center

 

PROFESSIONAL

CONSUMER

SIDE EFFECTS

 

Jalyn Side Effects Center

What Is Jalyn?

Jalyn (dutasteride and tamsulosin hydrochloride) is a combination of a benign prostatic hypertrophy agent and an alpha-blocker used in men to treat the symptoms of an enlarged prostate (benign prostatic hyperplasia-BPH).

What Are Side Effects of Jalyn?

Common side effects of Jalyn include:

Tell your doctor if you have serious side effects of Jalyn including:

  • fainting, or
  • a painful or prolonged erection lasting 4 or more hours.

Dosage for Jalyn

The recommended dosage of Jalyn is 1 capsule taken once daily approximately 30 minutes after the same meal each day.

What Drugs, Substances, or Supplements Interact with Jalyn?

Jalyn may interact with other alpha-blockers, drugs to treat erectile problems/pulmonary hypertension, azole antifungals, macrolide antibiotics, nefazodone, HIV protease inhibitors, telithromycin, other products that cause drowsiness including alcohol, antihistamines, drugs for sleep or anxiety, muscle relaxants, and narcotic pain relievers. Check labels on all medicines (such as allergy or cough-and-cold products) as they may contain ingredients that cause drowsiness. Tell your doctor all medications you are taking.

Jalyn During Pregnancy and Breastfeeding

This medication must not be used during pregnancy. It may harm a fetus. It is unknown if this medication passes into breast milk. This medication should not be used in women.

Additional Information

Our Jalyn (dutasteride and tamsulosin hydrochloride) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Jalyn Consumer Information

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Stop using dutasteride and tamsulosin and call your doctor at once if you have:

  • a light-headed feeling, like you might pass out; or
  • penis erection that is painful or lasts 4 hours or longer.

Common side effects may include:

  • decreased libido (sex drive);
  • decreased amount of semen released during sex;
  • impotence (trouble getting or keeping an erection);
  • breast tenderness or enlargement;
  • dizziness; or
  • runny nose.

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 Jalyn (Dutasteride and Tamsulosin Hydrochloride Capsules)

 

Jalyn Professional Information

SIDE EFFECTS

Clinical Trials Experience

The clinical efficacy and safety of coadministered dutasteride and tamsulosin, which are individual components of JALYN, have been evaluated in a multicenter, randomized, double-blind, parallel group trial (the Combination with Alpha-Blocker Therapy, or CombAT, trial). Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trial of another drug and may not reflect the rates observed in practice.

  • The most common adverse reactions reported in subjects receiving coadministered dutasteride and tamsulosin were impotence, decreased libido, breast disorders (including breast enlargement and tenderness), ejaculation disorders, and dizziness. Ejaculation disorders occurred significantly more in subjects receiving coadministration therapy (11%) compared with those receiving dutasteride (2%) or tamsulosin (4%) as monotherapy.
  • Trial withdrawal due to adverse reactions occurred in 6% of subjects receiving coadministered dutasteride and tamsulosin and in 4% of subjects receiving dutasteride or tamsulosin as monotherapy. The most common adverse reaction in all treatment arms leading to trial withdrawal was erectile dysfunction (1% to 1.5%).

In the CombAT trial, over 4,800 male subjects with BPH were randomly assigned to receive 0.5 mg dutasteride, 0.4 mg tamsulosin hydrochloride, or coadministration therapy (0.5 mg dutasteride and 0.4 mg tamsulosin hydrochloride) administered once daily in a 4-year double-blind trial. Overall, 1,623 subjects received monotherapy with dutasteride; 1,611 subjects received monotherapy with tamsulosin; and 1,610 subjects received coadministration therapy. The population was aged 49 to 88 years (mean age: 66 years) and 88% were white. Table 1 summarizes adverse reactions reported in at least 1% of subjects receiving coadministration therapy and at a higher incidence than subjects receiving either dutasteride or tamsulosin as monotherapy.

Table 1: Adverse Reactions Reported over a 48-Month Period in ≥1% of Subjects and More Frequently in the Coadministration Therapy Group than the Dutasteride or Tamsulosin Monotherapy Group (CombAT) by Time of Onset

Adverse ReactionAdverse Reaction Time of Onset
Year 1Year 2Year 3Year 4
Months 0-6Months 7-12
Coadministrationa(n = 1,610)(n = 1,527)(n = 1,428)(n = 1,283)(n = 1,200)
Dutasteride(n = 1,623)(n = 1,548)(n = 1,464)(n = 1,325)(n = 1,200)
Tamsulosin(n = 1,611)(n = 1,545)(n = 1,468)(n = 1,281)(n = 1,112)
Ejaculation disordersb,c
Coadministration7.8%1.6%1.0%0.5%<0.1%
Dutasteride1.0%0.5%0.5%0.2%0.3%
Tamsulosin2.2%0.5%0.5%0.2%0.3%
Impotencec,d
Coadministration5.4%1.1%1.8%0.9%0.4%
Dutasteride4.0%1.1%1.6%0.6%0.3%
Tamsulosin2.6%0.8%1.0%0.6%1.1%
Decreased libidoc,e
Coadministration4.5%0.9%0.8%0.2%0.0%
Dutasteride3.1%0.7%1.0%0.2%0.0%
Tamsulosin2.0%0.6%0.7%0.2%<0.1%
Breast disordersf
Coadministration1.1%1.1%0.8%0.9%0.6%
Dutasteride0.9%0.9%1.2%0.5%0.7%
Tamsulosin0.4%0.4%0.4%0.2%0.0%
Dizziness
Coadministration1.1%0.4%0.1%<0.1%0.2%
Dutasteride0.5%0.3%0.1%<0.1%<0.1%
Tamsulosin0.9%0.5%0.4%<0.1%0.0%
a Coadministration = AVODART 0.5 mg once daily plus tamsulosin 0.4 mg once daily.
b Includes anorgasmia, retrograde ejaculation, semen volume decreased, orgasmic sensation decreased, orgasm abnormal, ejaculation delayed, ejaculation disorder, ejaculation failure, and premature ejaculation.
c These sexual adverse reactions are associated with dutasteride treatment (including monotherapy and combination with tamsulosin). These adverse reactions may persist after treatment discontinuation. The role of dutasteride in this persistence is unknown.
d Includes erectile dysfunction and disturbance in sexual arousal.
e Includes libido decreased, libido disorder, loss of libido, sexual dysfunction, and male sexual dysfunction.
f Includes breast enlargement, gynecomastia, breast swelling, breast pain, breast tenderness, nipple pain, and nipple swelling.

Cardiac Failure

In CombAT, after 4 years of treatment, the incidence of the composite term cardiac failure in the coadministration group (12/1,610; 0.7%) was higher than in either monotherapy group: dutasteride, 2/1,623 (0.1%) and tamsulosin, 9/1,611 (0.6%). Composite cardiac failure was also examined in a separate 4-year placebo-controlled trial evaluating dutasteride in men at risk for development of prostate cancer. The incidence of cardiac failure in subjects taking dutasteride was 0.6% (26/4,105) compared with 0.4% (15/4,126) in subjects on placebo. A majority of subjects with cardiac failure in both trials had comorbidities associated with an increased risk of cardiac failure. Therefore, the clinical significance of the numerical imbalances in cardiac failure is unknown. No causal relationship between dutasteride alone or coadministered with tamsulosin and cardiac failure has been established. No imbalance was observed in the incidence of overall cardiovascular adverse events in either trial.

Additional information regarding adverse reactions in placebo-controlled trials with dutasteride or tamsulosin monotherapy follows.

Dutasteride

Long-term Treatment (Up To 4 Years): High-Grade Prostate Cancer

The REDUCE trial was a randomized, double-blind, placebo-controlled trial that enrolled 8,231 men aged 50 to 75 years with a serum PSA of 2.5 ng/mL to 10 ng/mL and a negative prostate biopsy within the previous 6 months. Subjects were randomized to receive placebo (n = 4,126) or 0.5-mg daily doses of dutasteride (n = 4,105) for up to 4 years. The mean age was 63 years and 91% were white. Subjects underwent protocol-mandated scheduled prostate biopsies at 2 and 4 years of treatment or had “for-cause biopsies” at non-scheduled times if clinically indicated. There was a higher incidence of Gleason score 8 to 10 prostate cancer in men receiving dutasteride (1.0%) compared with men on placebo (0.5%) [see INDICATIONS AND USAGE, WARNINGS AND PRECAUTIONS]. In a 7-year placebo-controlled clinical trial with another 5-alpha-reductase inhibitor (finasteride 5 mg, PROSCAR), similar results for Gleason score 8 to 10 prostate cancer were observed (finasteride 1.8% versus placebo 1.1%).

No clinical benefit has been demonstrated in patients with prostate cancer treated with dutasteride.

Reproductive And Breast Disorders

In the 3 pivotal placebo-controlled BPH trials with dutasteride, each 4 years in duration, there was no evidence of increased sexual adverse reactions (impotence, decreased libido, and ejaculation disorder) or breast disorders with increased duration of treatment. Among these 3 trials, there was 1 case of breast cancer in the dutasteride group and 1 case in the placebo group. No cases of breast cancer were reported in any treatment group in the 4-year CombAT trial or the 4-year REDUCE trial.

The relationship between long-term use of dutasteride and male breast neoplasia is currently unknown.

Tamsulosin

According to the tamsulosin prescribing information, in two 13-week treatment trials with tamsulosin monotherapy, adverse reactions occurring in at least 2% of subjects receiving 0.4 mg tamsulosin hydrochloride and at an incidence higher than in subjects receiving placebo were: infection, asthenia, back pain, chest pain, somnolence, insomnia, rhinitis, pharyngitis, cough increased, sinusitis, and diarrhea.

Signs And Symptoms Of Orthostasis

According to the tamsulosin prescribing information, in clinical trials with tamsulosin monotherapy, a positive orthostatic test result was observed in 16% (81/502) of subjects receiving 0.4 mg tamsulosin hydrochloride versus 11% (54/493) of subjects receiving placebo. Because orthostasis was detected more frequently in the tamsulosin-treated subjects than in placebo recipients, there is a potential risk of syncope [see WARNINGS AND PRECAUTIONS].

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of the individual components of JALYN. 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. These reactions have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to drug exposure.

Dutasteride

Immune System Disorders: Hypersensitivity reactions, including rash, pruritus, urticaria, localized edema, serious skin reactions, and angioedema.

Neoplasms: Male breast cancer.

Psychiatric Disorders: Depressed mood.

Reproductive System and Breast Disorders: Testicular pain and testicular swelling.

Tamsulosin

Immune System Disorders: Hypersensitivity reactions, including rash, urticaria, pruritus, angioedema, and respiratory problems have been reported with positive rechallenge in some cases.

Cardiac Disorders: Palpitations, dyspnea, atrial fibrillation, arrhythmia, and tachycardia.

Skin Disorders: Skin desquamation, including Stevens-Johnson syndrome, erythema multiforme, dermatitis exfoliative.

Gastrointestinal Disorders: Constipation, vomiting, dry mouth.

Reproductive System and Breast Disorders: Priapism.

Respiratory: Epistaxis.

Vascular Disorders: Hypotension.

Ophthalmologic Disorders: Blurred vision, visual impairment. During cataract and glaucoma surgery, a variant of small pupil syndrome known as Intraoperative Floppy Iris Syndrome (IFIS) associated with alpha-adrenergic-antagonist therapy [see WARNINGS AND PRECAUTIONS].

Read the entire FDA prescribing information for Jalyn (Dutasteride and Tamsulosin Hydrochloride Capsules)

&Copy; Jalyn Patient Information is supplied by Cerner Multum, Inc. and Jalyn Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.