Jalyn (dutasteride and tamsulosin hydrochloride)

Generic drug: dutasteride and tamsulosin hydrochloride

Brand name: Jalyn

Jalyn (dutasteride and tamsulosin hydrochloride) is a prescription medicine that contains 2 medicines: dutasteride and tamsulosin.

Jalyn is used to treat the symptoms of benign prostatic hyperplasia (BPH) in men with an enlarged prostate. The 2 medications in Jalyn work in different ways to improve symptoms of BPH. Dutasteride shrinks the enlarged prostate and tamsulosin relaxes muscles in the prostate and neck of the bladder.

These 2 medications, when used together, can improve symptoms of BPH better than either medication when used alone.

Jalyn may cause serious side effects including:

• Decreased blood pressure. Jalyn may cause a sudden drop in your blood pressure upon standing from a sitting or lying position, especially at the start of treatment. Symptoms of low blood pressure may include:
  • fainting
  • dizziness
  • feeling lightheaded
• Rare and serious allergic reactions, including:
  • swelling of your face, tongue, or throat
  • difficulty breathing
  • serious skin reactions, such as skin peeling
  • Get medical help right away if you have these serious allergic reactions.
• Higher chance of a more serious form of prostate cancer.
• Eye problems during cataract or glaucoma surgery. During cataract or glaucoma surgery, a condition called Intraoperative Floppy Iris Syndrome (IFIS) can happen if you take or have taken Jalyn in the past. If you need to have cataract or glaucoma surgery, tell your surgeon if you take or have taken Jalyn.
• A painful erection that will not go away. Rarely, Jalyn can cause a painful erection (priapism), which cannot be relieved by having sex. If this happens, get medical help right away. If priapism is not treated, there could be lasting damage to your penis, including not being able to have an erection.

The most common side effects of Jalyn include:

• ejaculation problems*
• trouble getting or keeping an erection (impotence)*
• a decrease in sex drive (libido)*
• dizziness
• enlarged or painful breasts. If you notice breast lumps or nipple discharge, you should talk to your healthcare provider.
• runny nose

*Some of these events may continue after you stop taking Jalyn.

Depressed mood has been reported in patients receiving dutasteride, an ingredient of Jalyn.

Dutasteride, an ingredient of Jalyn, has been shown to reduce sperm count, semen volume, and sperm movement. However, the effect of Jalyn on male fertility is not known.

Prostate-Specific Antigen (PSA) Test

• Your healthcare provider may check you for other prostate problems, including prostate cancer before you start and while you take Jalyn.
• A blood test called PSA (prostate-specific antigen) is sometimes used to see if you might have prostate cancer.
• Jalyn will reduce the amount of PSA measured in your blood.
• Your healthcare provider is aware of this effect and can still use PSA to see if you might have prostate cancer.
• Increases in your PSA levels while on treatment with Jalyn (even if the PSA levels are in the normal range) should be evaluated by your healthcare provider.
• These are not all the possible side effects with Jalyn.
• Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

• The recommended dosage of Jalyn is 1 capsule (0.5 mg dutasteride and 0.4 mg tamsulosin hydrochloride) taken once daily approximately 30 minutes after the same meal each day.
• The capsules should be swallowed whole and not chewed or opened. Contact with the contents of the Jalyn capsule may result in irritation of the oropharyngeal mucosa.

There have been no drug interaction trials using Jalyn. The following sections reflect information available for the individual components.

Cytochrome P450 Inhibition

Dutasteride

• Dutasteride is extensively metabolized in humans by the CYP3A4 and CYP3A5 isoenzymes.
• The effect of potent CYP3A4 inhibitors on dutasteride has not been studied.
• Because of the potential for drug-drug interactions, use caution when prescribing a dutasteride-containing product, including Jalyn, to patients taking potent, chronic CYP3A4 enzyme inhibitors (e.g., ritonavir).

Tamsulosin

Strong And Moderate Inhibitors Of CYP3A4 Or CYP2D6

• Tamsulosin is extensively metabolized, mainly by CYP3A4 or CYP2D6.
• Concomitant treatment with ketoconazole (a strong inhibitor of CYP3A4) resulted in increases in the Cmax and area under the concentration-time curve (AUC) of tamsulosin by factors of 2.2 and 2.8, respectively.
• Concomitant treatment with paroxetine (a strong inhibitor of CYP2D6) resulted in increases in the Cmax and AUC of tamsulosin by factors of 1.3 and 1.6, respectively.
• A similar increase in exposure is expected in poor metabolizers (PM) of CYP2D6 as compared to extensive metabolizers (EM).
• Since CYP2D6 PMs cannot be readily identified and the potential for significant increase in tamsulosin exposure exists when tamsulosin 0.4 mg is coadministered with strong CYP3A4 inhibitors in CYP2D6 PMs, tamsulosin 0.4 mg capsules should not be used in combination with strong inhibitors of CYP3A4 (e.g., ketoconazole).
• The effects of coadministration of both a CYP3A4 and a CYP2D6 inhibitor with tamsulosin have not been evaluated.
• However, there is a potential for significant increase in tamsulosin exposure when tamsulosin 0.4 mg is coadministered with a combination of both CYP3A4 and CYP2D6 inhibitors.

Cimetidine

• Treatment with cimetidine resulted in a moderate increase in tamsulosin hydrochloride AUC (44%).

Warfarin

Dutasteride

• Concomitant administration of dutasteride 0.5 mg/day for 3 weeks with warfarin does not alter the steady-state pharmacokinetics of the S- or R-warfarin isomers or alter the effect of warfarin on prothrombin time.

Tamsulosin

• A definitive drug-drug interaction trial between tamsulosin hydrochloride and warfarin was not conducted.
• Results from limited in vitro and in vivo studies are inconclusive.
• Caution should be exercised with concomitant administration of warfarin and tamsulosin-containing products, including Jalyn.

Nifedipine, Atenolol, Enalapril

Tamsulosin

• Dosage adjustments are not necessary when tamsulosin is administered concomitantly with nifedipine, atenolol, or enalapril.

Digoxin And Theophylline

Dutasteride

• Dutasteride does not alter the steady-state pharmacokinetics of digoxin when administered concomitantly at a dose of 0.5 mg/day for 3 weeks.

Tamsulosin

• Dosage adjustments are not necessary when tamsulosin is administered concomitantly with digoxin or theophylline.

Furosemide

Tamsulosin

• Tamsulosin had no effect on the pharmacodynamics (excretion of electrolytes) of furosemide.
• While furosemide produced an 11% to 12% reduction in tamsulosin hydrochloride Cmax and AUC, these changes are expected to be clinically insignificant and do not require adjustment of the dose of tamsulosin.

Calcium Channel Antagonists

Dutasteride

• Coadministration of verapamil or diltiazem decreases dutasteride clearance and leads to increased exposure to dutasteride. The change in dutasteride exposure is not considered to be clinically significant. No dosage adjustment of dutasteride is recommended.

Cholestyramine

Dutasteride

• Administration of a single 5-mg dose of dutasteride followed 1 hour later by a 12-g dose of cholestyramine does not affect the relative bioavailability of dutasteride.

• There are no adequate and well-controlled studies in pregnant women with Jalyn or its individual components.
• Jalyn is contraindicated for use in women of childbearing potential, including nursing women.
• It is not known whether dutasteride or tamsulosin is excreted in human milk.