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DOSAGE AND ADMINISTRATION
The recommended starting dosage of ORFADIN is 0.5 mg/kg orally twice daily. Titrate the dose for indiviudal patients, as needed based on biochemical and/or clinical response. Adjust the dose of nitisinone should be adjusted individually. Monitor plasma and/or urine succinylacetone concentrations, liver function parameters and alpha-fetoprotein levels. If succinylacetone is still detectable one month after the start of nitisinone treatment, increase the nitisinone dosage to 0.75 mg/kg twice daily. A maximum dosage of 1 mg/kg orally twice daily may be needed based on the evaluation of all biochemical parameters.
If the biochemical response is satisfactory, the dosage should be adjusted only according to body weight gain.
In addition to the tests above, during the initiation of therapy or if there is a deterioration in the patient's condition, it may be necessary to follow all available biochemical parameters more closely (i.e. plasma succinylacetone, urine 5-aminolevulinate (ALA) and erythrocyte porphobilinogen (PBG)-synthase activity).
Preparation And Administration Instructions
Preparation Of The Oral Suspension
The oral suspension will be dispensed with an oral syringe of appropriate size and a bottle adaptor provided by a pharmacist or other healthcare provider.
Preparing A Bottle Without The Adapter Already Inserted
- Store the bottle in the refrigerator prior to first use.
- Remove the bottle from the refrigerator. Calculate 60 days from when the bottle is removed from the refrigerator. Write this date as the “Discard after” date on the bottle label.
- Allow the bottle to warm to room temperature (30 to 60 minutes).
- Shake the bottle vigorously for at least 20 seconds until the solid cake at the bottom of the bottle is completely dispersed. Check that there are no particles left at the bottom of the bottle. Foam will form in the bottle.
- Insert the bottle adapter.
Preparing a Bottle With the Adapter Inserted
- Shake the bottle vigorously for at least 5 seconds. Check that there are no particles left at the bottom of the bottle. Foam will form in the bottle.
Measuring and Administering the Dose
Once the bottle is prepared with the adapter:
- Use the oral syringe to measure the dose.
- Keep the bottle upright and insert the oral syringe into the adapter.
- Carefully turn the bottle upside down with the oral syringe in place. Wait for the foam to rise to the top of the bottle.
- Pull back on the syringe plunger to withdraw the dose.
- Leave the syringe in the adapter and turn the bottle upright.
- Remove the syring efrom the adapter by gently twisting it out of the bottle.
- Dispense the dose into the patient's mouth.
- Do not remove the bottle adapter.
- Store the bottle at room temperature (not above 25°C).
Administration Of ORFADIN Capsules And Oral Suspension
- Maintain dietary restriction of tyrosine and phenylalanine when taking ORFADIN.
- Capsules: Take at least one hour before, or two hours after a meal [see CLINICAL PHARMACOLOGY]. For patients who have difficulty swallowing the capsules and who are intolerant to the oral suspension [see WARNINGS AND PRECAUTIONS), the capsules may be opened and the contents suspended in a small amount of water, formula or apple sauce immediately before use.
- Oral suspension: Take without regard to meals [see CLINICAL PHARMACOLOGY].
Dosage Forms And Strengths
- Capsules: 2 mg, 5 mg, and 10 mg white capsules imprinted with “NTBC” followed by “2 mg”, “5 mg”, or “10 mg”, indicating the actual amount of nitisinone in each capsule.
- Oral suspension: 4 mg/mL, a white, slightly viscous opaque suspension.
Storage And Handling
Capsules: White capsules marked in black with “NTBC” and identified as 2 mg, 5 mg or 10 mg strengths of nitisinone. The capsules are packed in a high density (HD) polyethylene container with a tamper-resistant low density (LD) polyethylene snap-on cap. Each bottle contains 60 capsules.
2 mg white capsules imprinted “NTBC 2 mg” in
black ink, NDC 66658-102-60
5 mg white capsules imprinted “NTBC 5 mg” in black ink, NDC 66658-105-60
10 mg white capsules imprinted “NTBC 10 mg” in black ink, NDC 66658-110-60
Store refrigerated, 2-8°C (36-46°F).
Oral suspension: White, slightly viscous opaque suspension. 1 mL contains 4 mg of nitisinone. The suspension is provided in a 100 mL brown bottle (type III glass) with a white child resistant HDPE screw cap with sealing and tamper evidence. Each bottle contains 90 mL oral suspension.
Oral suspension 4 mg/mL, NDC 66658-204-90
Store refrigerated at 2°C to 8°C (36°F to 46°F) prior to first use. Do not freeze. Store upright.
After first opening, store the product at room temperature (up to 25°C (77°F)) for up to 60 days. If not used within 60 days, discard unused portion. The discard after date should be noted on the bottle
Manufactured by: Apotek Produktion & Laboratorier AB, Sweden. Marketed by: Sobi, Inc 890 Winter Street Waltham, MA 02451. Revised: Apr 2016This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 6/21/2016
Additional Orfadin Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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