Jalyn

Dosage Forms & Strengths

dutasteride/tamsulosin

capsule

• 0.5mg/0.4mg

Benign Prostatic Hyperplasia

1 capsule PO 30 min after same meal once daily

Swallow capsule whole; do not chew, crush, or split

Contraindicated

• Take Jalyn exactly as your healthcare provider tells you to take it.
• Swallow Jalyn capsules whole. Do not crush, chew, or open Jalyn capsules because the contents of the capsule may irritate your lips, mouth, or throat.
• Take your Jalyn 1 time each day, about 30 minutes after the same meal every day. For example, you may take Jalyn 30 minutes after dinner every day.
• If you miss a dose, you can take it later that same day, 30 minutes after a meal. Do not take 2 Jalyn capsules in the same day. If you stop or forget to take Jalyn for several days, talk with your healthcare provider before starting again.
• If you take too much Jalyn, call your healthcare provider or go to the nearest hospital emergency room right away.

Dutasteride prevents the conversion of testosterone to dihydrotestosterone (DHT) in the body. DHT is involved in the development of benign prostatic hyperplasia (BPH).

Tamsulosin is in a group of drugs called alpha-adrenergic (AL-fa ad-ren-ER-jik) blockers. Tamsulosin relaxes the muscles in the prostate and bladder neck, making it easier to urinate.

The combination of dutasteride and tamsulosin is used to treat benign prostatic hyperplasia (BPH) in men with an enlarged prostate.

Dutasteride and tamsulosin may also be used for purposes not listed in this medication guide.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include extreme dizziness or fainting.

Note: Women of childbearing potential should not use or handle this medicine. Dutasteride can cause birth defects in male fetuses.

Dutasteride and tamsulosin combination is used to treat men who have symptoms of an enlarged prostate gland, which is also known as benign prostatic hyperplasia (BPH). Benign enlargement of the prostate is a problem that can occur in men as they get older. The prostate gland is located below the bladder. When the prostate gland gets larger, certain muscles in the gland get in the way of the tube that drains urine from the bladder. This can cause problems with urinating, such as a need to urinate often, a weak stream when urinating, or a feeling of not being able to empty the bladder completely.

Dutasteride blocks the action of an enzyme called 5-alpha-reductase. This enzyme changes testosterone to another hormone that causes the prostate gland to grow. Dutasteride will cause the size of the prostate to decrease, but the effect lasts only as long as the medicine is taken. If it is stopped, the prostate begins to grow again.

Tamsulosin helps relax the muscles in the prostate gland and the opening of the bladder. This may help increase the flow of urine or decrease symptoms.

This medicine is available only with your doctor's prescription.

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.

Women and children should not use this medicine. Pregnant women or women who may become pregnant should not handle or touch the capsules. Dutasteride can be absorbed through the skin and can cause birth defects in male fetuses. If a pregnant woman does come in contact with this medicine, the affected area should be washed right away with soap and water, especially if the capsule is broken.

Because this medicine may cause some people to become dizzy or feel faint, make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert.

Dizziness, lightheadedness, or fainting may occur after you take this medicine, especially when you get up suddenly from a lying or sitting position. Getting up slowly may help with this problem. If you feel dizzy, lie down so you do not faint. Then sit for a few moments before standing to prevent the dizziness from returning.

If you plan to have cataract surgery, tell your eye doctor (ophthalmologist) that you are taking this medicine or that you used this medicine in the previous 9 months. A serious eye problem called Intraoperative Floppy Iris Syndrome (IFIS) has occurred in some patients who were taking this medicine or who had recently taken this medicine when they had cataract surgery.

This medicine may affect the results of the prostate specific antigen (PSA) test, which may be used to detect prostate cancer. Make sure you tell all of your doctors that you are using this medicine.

This medicine will not prevent prostate cancer but may increase your risk of developing high-grade prostate cancer. Tell your doctor if you have concerns about this risk.

You should seek medical attention right away if you experience a prolonged erection while using this medicine. This is an extremely rare unwanted effect that must be treated right away to prevent permanent erectile damage (impotence).

Men who have taken this medicine should not donate blood until 6 months have passed since the last dose. Dutasteride can remain in your blood for a long time and be passed on to a pregnant woman who receives a blood transfusion.

This medicine does not usually affect normal sexual abilities for most men. You may notice that you ejaculate less fluid when you have sex.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Jalyn, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Jalyn. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Jalyn.

Review Date: October 4, 2017

Benign Prostatic Hyperplasia (BPH) Treatment

Jalyn® (dutasteride and tamsulosin hydrochloride) capsules are indicated for the treatment of symptomatic BPH in men with an enlarged prostate.

Limitations of Use

Dutasteride-containing products, including Jalyn, are not approved for the prevention of prostate cancer.

Orthostatic Hypotension

As with other alpha-adrenergic antagonists, orthostatic hypotension (postural hypotension, dizziness, and vertigo) may occur in patients treated with tamsulosin-containing products, including Jalyn, and can result in syncope. Patients starting treatment with Jalyn should be cautioned to avoid situations where syncope could result in an injury [see Adverse Reactions (6.1)].

Drug-drug Interactions

Strong Inhibitors of CYP3A4

Tamsulosin-containing products, including Jalyn, should not be coadministered with strong CYP3A4 inhibitors (e.g., ketoconazole) as this can significantly increase tamsulosin exposure [see Drug Interactions (7.1), Clinical Pharmacology (12.3)].

Inhibitors of CYP2D6 and Moderate Inhibitors of CYP3A4

Tamsulosin-containing products, including Jalyn, should be used with caution when coadministered with moderate inhibitors of CYP3A4 (e.g., erythromycin), strong (e.g., paroxetine) or moderate (e.g., terbinafine) inhibitors of CYP2D6, or in patients known to be poor metabolizers of CYP2D6, as there is a potential for significant increase in tamsulosin exposure [see Drug Interactions (7.1), Clinical Pharmacology (12.3)].

Cimetidine

Caution is advised when tamsulosin-containing products, including Jalyn, are coadministered with cimetidine [see Drug Interactions (7.1), Clinical Pharmacology (12.3)].

Other Alpha-adrenergic Antagonists

Tamsulosin-containing products, including Jalyn, should not be coadministered with other alpha-adrenergic antagonists because of the increased risk of symptomatic hypotension.

Phosphodiesterase-5 (PDE-5) Inhibitors

Caution is advised when alpha-adrenergic-antagonist-containing products, including Jalyn, are coadministered with PDE-5 inhibitors. Alpha-adrenergic antagonists and PDE-5 inhibitors are both vasodilators that can lower blood pressure. Concomitant use of these 2 drug classes can potentially cause symptomatic hypotension.

Warfarin

Caution should be exercised with concomitant administration of warfarin and tamsulosin-containing products, including Jalyn [see Drug Interactions (7.2), Clinical Pharmacology (12.3)].

Effects on Prostate-specific Antigen (PSA) and the Use of PSA in Prostate Cancer Detection

Coadministration of dutasteride with tamsulosin resulted in similar changes to serum PSA as with dutasteride monotherapy.

In clinical trials, dutasteride reduced serum PSA concentration by approximately 50% within 3 to 6 months of treatment. This decrease was predictable over the entire range of PSA values in patients with symptomatic BPH, although it may vary in individuals. Dutasteride-containing treatment, including Jalyn, may also cause decreases in serum PSA in the presence of prostate cancer. To interpret serial PSAs in men treated with a dutasteride-containing product, including Jalyn, a new baseline PSA should be established at least 3 months after starting treatment and PSA monitored periodically thereafter. Any confirmed increase from the lowest PSA value while on a dutasteride-containing treatment, including Jalyn, may signal the presence of prostate cancer and should be evaluated, even if PSA levels are still within the normal range for men not taking a 5-alpha-reductase inhibitor. Noncompliance with Jalyn may also affect PSA test results.

To interpret an isolated PSA value in a man treated with Jalyn, for 3 months or more, the PSA value should be doubled for comparison with normal values in untreated men.

The free-to-total PSA ratio (percent free PSA) remains constant, even under the influence of dutasteride. If clinicians elect to use percent free PSA as an aid in the detection of prostate cancer in men receiving Jalyn, no adjustment to its value appears necessary.

Increased Risk of High-grade Prostate Cancer

In men aged 50 to 75 years with a prior negative biopsy for prostate cancer and a baseline PSA between 2.5 ng/mL and 10.0 ng/mL taking dutasteride in the 4-year Reduction by Dutasteride of Prostate Cancer Events (REDUCE) trial, there was an increased incidence of Gleason score 8 to 10 prostate cancer compared with men taking placebo (dutasteride 1.0% versus placebo 0.5%) [see Indications and Usage (1.2), Adverse Reactions (6.1)]. 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%).

5-alpha-reductase inhibitors may increase the risk of development of high-grade prostate cancer. Whether the effect of 5-alpha-reductase inhibitors to reduce prostate volume or trial-related factors impacted the results of these trials has not been established.

Evaluation for Other Urological Diseases

Prior to initiating treatment with Jalyn, consideration should be given to other urological conditions that may cause similar symptoms. In addition, BPH and prostate cancer may coexist.

Exposure of WomenRisk to Male Fetus

Jalyn capsules should not be handled by a woman who is pregnant or who could become pregnant. Dutasteride is absorbed through the skin and could result in unintended fetal exposure. If a woman who is pregnant or could become pregnant comes in contact with a leaking capsule, the contact area should be washed immediately with soap and water [see Use in Specific Populations (8.1)].

Priapism

Priapism (persistent painful penile erection unrelated to sexual activity) has been associated (probably less than 1 in 50,000) with the use of alpha-adrenergic antagonists, including tamsulosin, which is a component of Jalyn. Because this condition can lead to permanent impotence if not properly treated, patients should be advised about the seriousness of the condition.

Blood Donation

Men being treated with a dutasteride-containing product, including Jalyn, should not donate blood until at least 6 months have passed following their last dose. The purpose of this deferred period is to prevent administration of dutasteride to a pregnant female transfusion recipient.

Intraoperative Floppy Iris Syndrome

Intraoperative Floppy Iris Syndrome (IFIS) has been observed during cataract surgery in some patients on or previously treated with alpha-adrenergic antagonists, including tamsulosin, which is a component of Jalyn.

Most reports were in patients taking the alpha-adrenergic antagonist when IFIS occurred, but in some cases, the alpha-adrenergic antagonist had been stopped prior to surgery. In most of these cases, the alpha-adrenergic antagonist had been stopped recently prior to surgery (2 to 14 days), but in a few cases, IFIS was reported after the patients had been off the alpha-adrenergic antagonist for a longer period (5 weeks to 9 months). IFIS is a variant of small pupil syndrome and is characterized by the combination of a flaccid iris that billows in response to intraoperative irrigation currents, progressive intraoperative miosis despite preoperative dilation with standard mydriatic drugs, and potential prolapse of the iris toward the phacoemulsification incisions. The patient’s ophthalmologist should be prepared for possible modifications to their surgical technique, such as the utilization of iris hooks, iris dilator rings, or viscoelastic substances.

IFIS may increase the risk of eye complications during and after the operation. The benefit of stopping alpha-adrenergic antagonist therapy prior to cataract surgery has not been established. The initiation of therapy with tamsulosin in patients for whom cataract surgery is scheduled is not recommended.

Sulfa Allergy

In patients with sulfa allergy, allergic reaction to tamsulosin has been rarely reported. If a patient reports a serious or life-threatening sulfa allergy, caution is warranted when administering tamsulosin-containing products, including Jalyn.

Effect on Semen Characteristics

Dutasteride

The effects of dutasteride 0.5 mg/day on semen characteristics were evaluated in normal volunteers aged 18 to 52 (n = 27 dutasteride, n = 23 placebo) throughout 52 weeks of treatment and 24 weeks of post-treatment follow-up. At 52 weeks, the mean percent reductions from baseline in total sperm count, semen volume, and sperm motility were 23%, 26%, and 18%, respectively, in the dutasteride group when adjusted for changes from baseline in the placebo group. Sperm concentration and sperm morphology were unaffected. After 24 weeks of follow-up, the mean percent change in total sperm count in the dutasteride group remained 23% lower than baseline. While mean values for all semen parameters at all time-points remained within the normal ranges and did not meet predefined criteria for a clinically significant change (30%), 2 subjects in the dutasteride group had decreases in sperm count of greater than 90% from baseline at 52 weeks, with partial recovery at the 24-week follow-up. The clinical significance of dutasteride’s effect on semen characteristics for an individual patient’s fertility is not known.

Tamsulosin

The effects of tamsulosin hydrochloride on sperm counts or sperm function have not been evaluated.

You should not use Jalyn if you are allergic to dutasteride (Avodart) or tamsulosin (Flomax). Do not take Jalyn if you are also taking alfuzosin (Uroxatral), doxazosin (Cardura), prazosin (Minipress), silodosin (Rapaflo), tamsulosin (Flomax), or terazosin (Hytrin).

Jalyn should never be taken by a woman, a child, or a teenager. Dutasteride can be absorbed through the skin, and women or children should not be permitted to handle Jalyn capsules. This medication can cause birth defects if a woman is exposed to it during pregnancy. Jalyn capsules should not be handled by a woman who is pregnant or who may become pregnant. If a woman accidentally comes into contact with the medication from a leaking capsule, wash the area with soap and water right away. Do not donate blood while taking Jalyn and for at least 6 months after your treatment ends. Dutasteride can be carried in the blood and could cause birth defects if a pregnant women receives a transfusion with blood that contains dutasteride.

Jalyn may increase your risk of developing prostate cancer. Your doctor will perform tests to make sure you do not have other conditions that would prevent you from safely using Jalyn.

Tamsulosin can affect your pupils during cataract surgery. Tell your eye surgeon ahead of time that you are using this medication. Do not stop using Jalyn before surgery unless your surgeon tells you to.

There are many other drugs that can interact with dutasteride and tamsulosin. Tell your doctor about all medications you use.

Take Jalyn exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Jalyn is usually taken once a day, approximately 30 minutes after a meal. Try to take this medication at the same time each day. Do not crush, chew, or open a Jalyn capsule. Swallow it whole. A broken or leaking capsule can irritate your lips, mouth, or throat. Tamsulosin lowers blood pressure and may cause dizziness or fainting, especially when you first start taking Jalyn. Call your doctor if you have severe dizziness or feel like you might pass out. It may take up to 6 months before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve.

To be sure Jalyn is helping your condition and not causing harmful effects, your blood may need to be tested often. Your doctor will also test your prostate specific antigen (PSA) to check for prostate cancer. Visit your doctor regularly.

Store Jalyn at room temperature away from moisture and heat. Do not use a capsule that has been exposed to high heat, which can cause the capsule to change shape or color.