Version May 2024
Deutetrabenazine can increase the risk of depression and suicidal thoughts and behavior (suicidality) in patients with Huntington disease. Anyone considering the use of deutetrabenazine must balance the risks of depression and suicidality with the clinical need for treatment of chorea. Closely monitor patients for the emergence or worsening of depression, suicidality, or unusual changes in behavior. Patients, their caregivers, and families should be informed of the risk of depression and suicidality and should be instructed to report behaviors of concern promptly to the treating physician.
Particular caution should be exercised in treating patients with a history of depression or prior suicide attempts or ideation, which are increased in frequency in Huntington disease. Deutetrabenazine is contraindicated in patients who are suicidal, and in patients with untreated or inadequately treated depression.
Note: Dose should be individualized. Maximum dose in CYP2D6 poor metabolizers is 36 mg/day.
Huntington disease–associated chorea:
Immediate release: Oral: Initial: 6 mg twice daily; may increase dose weekly based on response and tolerability in increments of 6 mg/day; administer in 2 divided doses if total dose ≥12 mg/day; maximum recommended dose: 48 mg/day.
Extended release: Oral: Initial: 12 mg once daily; may increase dose weekly based on response and tolerability in increments of 6 mg/day, administered once daily; maximum recommended dose: 48 mg/day.
Tardive dyskinesia:
Immediate release: Oral: Initial: 6 mg twice daily; may increase dose weekly based on response and tolerability in increments of 6 mg/day. Administer in 2 divided doses if total dose ≥12 mg/day; maximum recommended dose: 48 mg/day.
Extended release: Oral: Initial: 12 mg once daily; may increase dose weekly based on response and tolerability in increments of 6 mg/day, administered once daily; maximum recommended dose: 48 mg/day.
CYP2D6 poor metabolizers: Maximum dose: 36 mg/day.
Switching from immediate release to extended release : The same total daily dose of deutetrabenazine should be used.
Conversion from tetrabenazine: Discontinue tetrabenazine and initiate deutetrabenazine the following day, using the following conversion. May adjust dose weekly based on response and tolerability.
|
Current tetrabenazine daily dose |
Initial deutetrabenazine ER tablet dose |
Initial deutetrabenazine IR tablet dose |
|---|---|---|
|
12.5 mg |
6 mg once daily |
6 mg once daily |
|
25 mg |
12 mg once daily |
6 mg twice daily |
|
37.5 mg |
18 mg once daily |
9 mg twice daily |
|
50 mg |
24 mg once daily |
12 mg twice daily |
|
62.5 mg |
30 mg once daily |
15 mg twice daily |
|
75 mg |
36 mg once daily |
18 mg twice daily |
|
87.5 mg |
42 mg once daily |
21 mg twice daily |
|
100 mg |
48 mg once daily |
24 mg twice daily |
Reinitiation of therapy: If dosing is interrupted for <7 days, resume at previous maintenance dose. If dosing is interrupted for ≥7 days, retitrate when resuming.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied).
Use is contraindicated.
Akathisia; parkinsonism: Reduce dose; therapy discontinuation may be necessary.
Depression or suicidality, unresolving: Consider discontinuation of therapy.
Hyperprolactinemia, symptomatic: Initiate appropriate laboratory assessment and consider discontinuation of therapy.
Neuroleptic malignant syndrome: Immediately discontinue deutetrabenazine; monitor and manage symptoms and concomitant complications. If deutetrabenazine therapy is reinitiated after recovery, monitor for signs of recurrence.
Refer to adult dosing; use with caution.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>10%: Central nervous system: Drowsiness (11%)
1% to 10%:
Central nervous system: Fatigue (9%), insomnia (4% to 7%), anxiety (4%), depression (≤4%), agitation (≤4%), akathisia (≤4%), restlessness (≤4%), suicidal ideation (2%)
Gastrointestinal: Diarrhea (9%), xerostomia (9%), constipation (4%)
Genitourinary: Urinary tract infection (7%)
Hematologic & oncologic: Bruise (4%)
Respiratory: Nasopharyngitis (4%)
Frequency not defined:
Central nervous system: Sedation
Hepatic impairment; patients with Huntington disease who are suicidal or have untreated or inadequately treated depression; coadministration with tetrabenazine or valbenazine; coadministration with or within 14 days of discontinuing monoamine oxidase inhibitors (MAOIs); coadministration with or within 20 days of discontinuing reserpine.
Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Concerns related to adverse effects:
• Akathisia: Use has been associated with akathisia; monitor for signs and symptoms of restlessness and agitation. Dosage reduction or discontinuation may be necessary.
• CNS depression: May cause CNS depression, which may impair physical or mental abilities; patients must be cautioned about performing tasks that require mental alertness (eg, operating machinery, driving).
• Hyperprolactinemia: May increase prolactin levels; clinical significance of hyperprolactinemia in patients with breast cancer or other prolactin-dependent tumors is unknown.
• Neuroleptic malignant syndrome: Use may be associated with neuroleptic malignant syndrome (NMS); monitor for mental status changes, fever, muscle rigidity and/or autonomic instability. Discontinue with confirmed NMS; may recur with reintroduction of treatment; monitor carefully.
• Ophthalmic effects: Binds to melanin-containing tissues in animal studies; may result in accumulation and toxicity with extended use and long-term ophthalmic effects. Clinical relevance and monitoring recommendations are unknown.
• Parkinsonism: Parkinsonism, including bradykinesia and gait disturbances (leading to falls or the emergence/worsening of tremor in some cases), has been reported in patients with Huntington disease. Most cases occurred within 2 weeks of initiation or dose escalation and resolved following discontinuation. Development of these symptoms may be difficult to differentiate from progression of the underlying disease; dose reduction or discontinuation of therapy may be necessary.
• QTc prolongation: QTc prolongation may occur but is found to be clinically insignificant when deutetrabenazine is administered within the recommended dosage range. Avoid use in patients with congenital QT prolongation or a history of cardiac arrhythmias. Risk may be increased in patients with bradycardia, hypokalemia, hypomagnesemia, concomitant use of drugs known to cause QT prolongation, or presence of congenital QTc prolongation.
Special populations:
• CYP2D6 poor metabolizers: CYP2D6 poor metabolizers have increased levels of primary drug metabolites; maximum dosage should not exceed 36 mg/day in poor metabolizers.
• Huntington disease: May worsen mood, cognition, rigidity, and functional capacity in patients with Huntington disease, which can be difficult to differentiate from progression of the underlying disease. Underlying chorea may improve over time in some patients, thereby decreasing the need for therapy. Reevaluate patients' need for treatment by periodically assessing the effect on chorea and possible adverse effects. Dose reduction or discontinuation of therapy may be necessary.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet, Oral:
Austedo: 6 mg [contains fd&c blue #2 (indigo carm) aluminum lake, fd&c red #40(allura red ac)aluminum lake]
Austedo: 9 mg [contains fd&c blue #2 (indigo carm) aluminum lake]
Austedo: 12 mg [contains fd&c blue #2 (indigo carm) aluminum lake, fd&c yellow #6(sunset yellow)alumin lake]
Tablet Extended Release 24 Hour, Oral:
Austedo XR: 6 mg, 12 mg [contains fd&c blue #2 (indigo carm) aluminum lake, fd&c red #40(allura red ac)aluminum lake, fd&c yellow #6(sunset yellow)alumin lake]
Austedo XR: 24 mg [contains fd&c blue #2 (indigo carm) aluminum lake, fd&c red #40(allura red ac)aluminum lake]
Tablet Extended Release Therapy Pack, Oral:
Austedo XR Patient Titration: 6 & 12 & 24 MG (42 ea) [contains fd&c blue #2 (indigo carm) aluminum lake, fd&c red #40(allura red ac)aluminum lake, fd&c yellow #6(sunset yellow)alumin lake]
No
Tablet Extended Release Therapy Pack (Austedo XR Patient Titration Oral)
6 & 12 & 24 mg (per each): $195.24
Tablet, 24-hour (Austedo XR Oral)
6 mg (per each): $97.62
12 mg (per each): $195.24
24 mg (per each): $292.86
Tablets (Austedo Oral)
6 mg (per each): $97.62
9 mg (per each): $109.82
12 mg (per each): $146.43
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Oral:
Immediate release: Administer with food. Manufacturer labeling recommends that tablets should be swallowed whole, not chewed, crushed, or broken; however, a case report describes crushing deutetrabenazine 6 mg tablets and dissolving in 10 to 20 mL of sterile water for PEG tube administration, flushing the PEG tube before and after administration with 15 mL sterile water, with no reported adverse effects (Ref).
Extended release: Administer with or without food. Swallow whole; do not break, chew, or crush.
An FDA-approved patient medication guide, which is available with the product information and as follows, must be dispensed with this medication:
Austedo: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/216354s000lbl.pdf#page=29
Chorea associated with Huntington disease: Treatment of chorea associated with Huntington disease in adults.
Tardive dyskinesia: Treatment of tardive dyskinesia in adults.
Substrate of CYP1A2 (minor), CYP2D6 (major), CYP3A4 (minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Ajmaline: May increase the serum concentration of CYP2D6 Substrates (High risk with Inhibitors). Risk C: Monitor therapy
Alcohol (Ethyl): CNS Depressants may enhance the CNS depressant effect of Alcohol (Ethyl). Risk C: Monitor therapy
Alizapride: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy
Antipsychotic Agents: Deutetrabenazine may enhance the adverse/toxic effect of Antipsychotic Agents. Specifically, the risk for akathisia, parkinsonism, or neuroleptic malignant syndrome may be increased. Risk C: Monitor therapy
Artemether and Lumefantrine: May increase the serum concentration of CYP2D6 Substrates (High risk with Inhibitors). Risk C: Monitor therapy
Azelastine (Nasal): May enhance the CNS depressant effect of CNS Depressants. Risk X: Avoid combination
Blonanserin: CNS Depressants may enhance the CNS depressant effect of Blonanserin. Management: Use caution if coadministering blonanserin and CNS depressants; dose reduction of the other CNS depressant may be required. Strong CNS depressants should not be coadministered with blonanserin. Risk D: Consider therapy modification
Brexanolone: CNS Depressants may enhance the CNS depressant effect of Brexanolone. Risk C: Monitor therapy
Brimonidine (Topical): May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy
Bromopride: May enhance the adverse/toxic effect of Deutetrabenazine. Specifically, the risk for akathisia, parkinsonism, or neuroleptic malignant syndrome may be increased. Risk C: Monitor therapy
Bromperidol: May enhance the CNS depressant effect of CNS Depressants. Risk X: Avoid combination
Buprenorphine: CNS Depressants may enhance the CNS depressant effect of Buprenorphine. Management: Consider reduced doses of other CNS depressants, and avoiding such drugs in patients at high risk of buprenorphine overuse/self-injection. Initiate buprenorphine at lower doses in patients already receiving CNS depressants. Risk D: Consider therapy modification
Cannabinoid-Containing Products: CNS Depressants may enhance the CNS depressant effect of Cannabinoid-Containing Products. Risk C: Monitor therapy
Chlormethiazole: May enhance the CNS depressant effect of CNS Depressants. Management: Monitor closely for evidence of excessive CNS depression. The chlormethiazole labeling states that an appropriately reduced dose should be used if such a combination must be used. Risk D: Consider therapy modification
Chlorphenesin Carbamate: May enhance the adverse/toxic effect of CNS Depressants. Risk C: Monitor therapy
CNS Depressants: May enhance the adverse/toxic effect of other CNS Depressants. Risk C: Monitor therapy
CYP2D6 Inhibitors (Moderate): May increase serum concentrations of the active metabolite(s) of Deutetrabenazine. Risk C: Monitor therapy
CYP2D6 Inhibitors (Strong): May increase serum concentrations of the active metabolite(s) of Deutetrabenazine. Management: The total daily dose of deutetrabenazine should not exceed 36 mg with concurrent use of a strong CYP2D6 inhibitor. Risk D: Consider therapy modification
Daridorexant: May enhance the CNS depressant effect of CNS Depressants. Management: Dose reduction of daridorexant and/or any other CNS depressant may be necessary. Use of daridorexant with alcohol is not recommended, and the use of daridorexant with any other drug to treat insomnia is not recommended. Risk D: Consider therapy modification
DexmedeTOMIDine: CNS Depressants may enhance the CNS depressant effect of DexmedeTOMIDine. Management: Monitor for increased CNS depression during coadministration of dexmedetomidine and CNS depressants, and consider dose reductions of either agent to avoid excessive CNS depression. Risk D: Consider therapy modification
Difelikefalin: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy
Dimethindene (Topical): May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy
Doxylamine: CNS Depressants may enhance the CNS depressant effect of Doxylamine. Risk C: Monitor therapy
DroPERidol: May enhance the CNS depressant effect of CNS Depressants. Management: Consider dose reductions of droperidol or of other CNS agents (eg, opioids, barbiturates) with concomitant use. Risk D: Consider therapy modification
Esketamine: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy
Flunarizine: CNS Depressants may enhance the CNS depressant effect of Flunarizine. Risk X: Avoid combination
Flunitrazepam: CNS Depressants may enhance the CNS depressant effect of Flunitrazepam. Management: Reduce the dose of CNS depressants when combined with flunitrazepam and monitor patients for evidence of CNS depression (eg, sedation, respiratory depression). Use non-CNS depressant alternatives when available. Risk D: Consider therapy modification
Haloperidol: QT-prolonging Agents (Indeterminate Risk - Caution) may enhance the QTc-prolonging effect of Haloperidol. Risk C: Monitor therapy
HydrOXYzine: May enhance the CNS depressant effect of CNS Depressants. Management: Consider a decrease in the CNS depressant dose, as appropriate, when used together with hydroxyzine. Increase monitoring of signs/symptoms of CNS depression in any patient receiving hydroxyzine together with another CNS depressant. Risk D: Consider therapy modification
Ixabepilone: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy
Kava Kava: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy
Kratom: May enhance the CNS depressant effect of CNS Depressants. Risk X: Avoid combination
Lemborexant: May enhance the CNS depressant effect of CNS Depressants. Management: Dosage adjustments of lemborexant and of concomitant CNS depressants may be necessary when administered together because of potentially additive CNS depressant effects. Close monitoring for CNS depressant effects is necessary. Risk D: Consider therapy modification
Levodopa-Foslevodopa: Vesicular Monoamine Transporter 2 (VMAT2) Inhibitors may diminish the therapeutic effect of Levodopa-Foslevodopa. Management: Consider alternatives to the coadministration of levodopa and vesicular monoamine transporter 2 (VMAT2) inhibitors. If combined, monitor for reduced levodopa efficacy. Risk D: Consider therapy modification
Lisuride: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy
Lofexidine: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy
Magnesium Sulfate: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy
Methotrimeprazine: CNS Depressants may enhance the CNS depressant effect of Methotrimeprazine. Methotrimeprazine may enhance the CNS depressant effect of CNS Depressants. Management: Reduce the usual dose of CNS depressants by 50% if starting methotrimeprazine until the dose of methotrimeprazine is stable. Monitor patient closely for evidence of CNS depression. Risk D: Consider therapy modification
Metoclopramide: Deutetrabenazine may enhance the adverse/toxic effect of Metoclopramide. Specifically, the risk for akathisia, parkinsonism, or neuroleptic malignant syndrome may be increased. Risk C: Monitor therapy
MetyroSINE: May enhance the adverse/toxic effect of Vesicular Monoamine Transporter 2 (VMAT2) Inhibitors. Specifically, the risk for extrapyramidal symptoms and excessive sedation may be increased. Risk C: Monitor therapy
Minocycline (Systemic): May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy
Monoamine Oxidase Inhibitors: May enhance the adverse/toxic effect of Deutetrabenazine. Risk X: Avoid combination
Nabilone: May enhance the CNS depressant effect of CNS Depressants. Risk X: Avoid combination
Olopatadine (Nasal): May enhance the CNS depressant effect of CNS Depressants. Risk X: Avoid combination
Opioid Agonists: CNS Depressants may enhance the CNS depressant effect of Opioid Agonists. Management: Avoid concomitant use of opioid agonists and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug. Risk D: Consider therapy modification
Orphenadrine: CNS Depressants may enhance the CNS depressant effect of Orphenadrine. Risk X: Avoid combination
Oxomemazine: May enhance the CNS depressant effect of CNS Depressants. Risk X: Avoid combination
Oxybate Salt Products: CNS Depressants may enhance the CNS depressant effect of Oxybate Salt Products. Management: Consider alternatives to this combination when possible. If combined, dose reduction or discontinuation of one or more CNS depressants (including the oxybate salt product) should be considered. Interrupt oxybate salt treatment during short-term opioid use Risk D: Consider therapy modification
OxyCODONE: CNS Depressants may enhance the CNS depressant effect of OxyCODONE. Management: Avoid concomitant use of oxycodone and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug. Risk D: Consider therapy modification
Paraldehyde: CNS Depressants may enhance the CNS depressant effect of Paraldehyde. Risk X: Avoid combination
Peginterferon Alfa-2b: May decrease the serum concentration of CYP2D6 Substrates (High risk with Inhibitors). Peginterferon Alfa-2b may increase the serum concentration of CYP2D6 Substrates (High risk with Inhibitors). Risk C: Monitor therapy
Perampanel: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy
Piribedil: CNS Depressants may enhance the CNS depressant effect of Piribedil. Risk C: Monitor therapy
Pramipexole: CNS Depressants may enhance the sedative effect of Pramipexole. Risk C: Monitor therapy
Procarbazine: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy
QT-prolonging Agents (Highest Risk): QT-prolonging Agents (Indeterminate Risk - Caution) may enhance the QTc-prolonging effect of QT-prolonging Agents (Highest Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy
Reserpine: May enhance the adverse/toxic effect of Deutetrabenazine. Risk X: Avoid combination
Ropeginterferon Alfa-2b: CNS Depressants may enhance the adverse/toxic effect of Ropeginterferon Alfa-2b. Specifically, the risk of neuropsychiatric adverse effects may be increased. Management: Avoid coadministration of ropeginterferon alfa-2b and other CNS depressants. If this combination cannot be avoided, monitor patients for neuropsychiatric adverse effects (eg, depression, suicidal ideation, aggression, mania). Risk D: Consider therapy modification
ROPINIRole: CNS Depressants may enhance the sedative effect of ROPINIRole. Risk C: Monitor therapy
Rotigotine: CNS Depressants may enhance the sedative effect of Rotigotine. Risk C: Monitor therapy
Rufinamide: May enhance the adverse/toxic effect of CNS Depressants. Specifically, sleepiness and dizziness may be enhanced. Risk C: Monitor therapy
Suvorexant: CNS Depressants may enhance the CNS depressant effect of Suvorexant. Management: Dose reduction of suvorexant and/or any other CNS depressant may be necessary. Use of suvorexant with alcohol is not recommended, and the use of suvorexant with any other drug to treat insomnia is not recommended. Risk D: Consider therapy modification
Tetrabenazine: Deutetrabenazine may enhance the adverse/toxic effect of Tetrabenazine. Risk X: Avoid combination
Thalidomide: CNS Depressants may enhance the CNS depressant effect of Thalidomide. Risk X: Avoid combination
Trimeprazine: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy
Valbenazine: Deutetrabenazine may enhance the adverse/toxic effect of Valbenazine. Risk X: Avoid combination
Valerian: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy
Zolpidem: CNS Depressants may enhance the CNS depressant effect of Zolpidem. Management: Reduce the Intermezzo brand sublingual zolpidem adult dose to 1.75 mg for men who are also receiving other CNS depressants. No such dose change is recommended for women. Avoid use with other CNS depressants at bedtime; avoid use with alcohol. Risk D: Consider therapy modification
Zuranolone: May enhance the CNS depressant effect of CNS Depressants. Management: Consider alternatives to the use of zuranolone with other CNS depressants or alcohol. If combined, consider a zuranolone dose reduction and monitor patients closely for increased CNS depressant effects. Risk D: Consider therapy modification
Although not evaluated in preclinical studies, deutetrabenazine may increase serum prolactin concentrations which may lead to amenorrhea or impotence.
Adverse events were not observed in available animal reproduction studies.
It is not known if deutetrabenazine or its metabolites are present in breast milk. According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother.
Administer IR tablets with food.
Electrolytes; EKG; signs/symptoms of depression or suicidal ideation; signs and/or symptoms of NMS, restlessness and agitation.
The precise mechanism by which deutetrabenazine exerts its effects is unknown. Its major metabolites (alpha-dihydrotetrabenazine [HTBZ] and beta-HTBZ) act as reversible inhibitors of the human vesicular monoamine transporter type 2 (VMAT-2) and thereby decrease the uptake of monoamines (including dopamine, serotonin, norepinephrine, and histamine) into synaptic vesicles and deplete the monoamine stores.
Distribution: alpha-HTBZ: ~500 L; beta-HTBZ: 730 L.
Protein binding: alpha-HTBZ: 60% to 68%; beta-HTBZ: 59% to 63%.
Metabolism: Extensive hepatic metabolism via carbonyl reductase to alpha-dihydrotetrabenazine (HTBZ) and beta-HTBZ (active major metabolites), which are subsequently metabolized via CYP2D6 (minor contributions of CYP1A2 and CYP3A4/5) to form several minor metabolites.
Bioavailability: 80%.
Half-life elimination: 9 to 10 hours.
Time to peak, plasma: 3 to 4 hours.
Excretion: Urine (75% to 86%; <10% as active major metabolites); feces (8% to 11%).
Poor CYP2D6 metabolizers: It is likely that the exposure to alpha-HTBZ and beta-HTBZ would be increased ~3-fold.
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