Ipsen Biopharmaceuticals, Inc.

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Ipsen Biopharmaceuticals, Inc. Drugs

Pancrezyme

Pancrezyme

Somatuline Depot should be administered by healthcare professionals. Please see enclosed Instructions for Use Leaflet for administration of Somatuline Depot.
2.1 Acromegaly

Patients should begin treatment with SOMATULINE DEPOT 90 mg given via the deep subcutaneous route, at 4-week intervals for 3 months.

After 3 months, dosage may be adjusted as follows:
GH greater than 1ng/mL to less than or equal to 2.5 ng/mL, IGF-1 normal, and clinical symptoms controlled: maintain SOMATULINE DEPOT dose at 90 mg every 4 weeks GH greater than 2.5 ng/mL, IGF-1 elevated, and/or clinical symptoms uncontrolled: increase SOMATULINE DEPOT dose to 120 mg every 4 weeks. GH less than or equal to 1 ng/mL, IGF-1 normal, and clinical symptoms controlled: reduce SOMATULINE DEPOT dose to 60 mg every 4 weeks.
Thereafter, the dose should be adjusted according to the response of the patient as judged by a reduction in serum GH and/or IGF-1 levels; and/or changes in symptoms of acromegaly.

Patients who are controlled on SOMATULINE DEPOT 60 mg or 90 mg may be considered for an extended dosing interval of SOMATULINE DEPOT 120 mg every 6 or 8 weeks. GH and IGF-1 levels should be obtained 6 weeks after this change in dosing regimen to evaluate persistence of patient response.

Continued monitoring of patient response with dose adjustments for biochemical and clinical symptom control, as necessary, is recommended.

The starting dose in patients with moderate or severe renal impairment or moderate or severe hepatic impairment should be 60 mg via the deep subcutaneous route at 4-week intervals for 3 months followed by dose adjustment as described above [see Clinical Pharmacology (12.3)].

2.2 Gastroenteropancreatic Neuroendocrine Tumors

The recommended dose of SOMATULINE DEPOT is 120 mg administered every 4 weeks by deep subcutaneous injection. There is no recommended dose adjustment for mild or moderate renal impairment. There is insufficient information to recommend a dose for patients with severe renal impairment or with hepatic impairment of any severity [see Clinical Pharmacology (12.3)].

2.3 Administration

SOMATULINE DEPOT is provided in a single-dose, prefilled syringe affixed with an automatic needle protection system. Inject SOMATULINE DEPOT via the deep subcutaneous route in the superior external quadrant of the buttock. Alternate the injection site between the right and left sides from one injection to the next. Remove SOMATULINE DEPOT from the refrigerator 30 minutes prior to administration. Keep pouch sealed until just prior to injection.
Bupropion Hydrochloride...

Bupropion Hydrochloride

2.1 Instructions for Safe Use

The potency Units of DYSPORT® are specific to the preparation and assay method utilized. They are not interchangeable with other preparations of botulinum toxin products and, therefore, units of biological activity of DYSPORT® cannot be compared to or converted into units of any other botulinum toxin products assessed with any other specific assay method [see Description (11)]. Reconstituted DYSPORT® is intended for intramuscular injection only.

Reconstitution instructions are specific for each of the 300 Unit vial and the 500 Unit vial. These volumes yield concentrations specific for the use for each indication (Table 1).
Table 1: Dilution Instructions for DYSPORT® Vials (500 Units and 300 Units) Diluent* per 500 Unit Vial Resulting Dose Units per 0.1 mL Diluent* per 300 Unit Vial Resulting Dose Units per 0.1 mL Note: These dilutions are calculated for an injection volume of 0.1 mL. A decrease or increase in the DYSPORT® dose is also possible by administering a smaller or larger injection volume (i.e. 0.05 mL (50% decrease in dose), 0.08 mL (20% decrease in dose) or 0.15 mL (50% increase in dose)). * Preservative-free 0.9% Sodium Chloride Injection, USP Only † When using 5 mL of diluent for a 500 Unit vial of DYSPORT ®, complete the following steps (see also 2.4 Dosing in Upper Limb Spasticity). Reconstitute a 500 Unit vial of DYSPORT® with 2.5 mL of Preservative-free 0.9% Sodium Chloride Injection, USP, gently mix, and set the vial aside. Withdraw 2.5 mL of Preservative-free 0.9% Sodium Chloride Injection, USP, into a 5 mL syringe. Take the 5 mL syringe with 2.5 mL Preservative-free 0.9% Sodium Chloride Injection, USP, and draw up the DYSPORT® solution from the reconstituted vial without inverting and mix gently. The resulting concentration will be 10 units/0.1 mL. Use immediately after reconstitution in the syringe. Dispose of any unused saline. 1 mL 50 Units 0.6 mL 50 Units 2.5 mL 20 Units 1.5 mL 20 Units -- -- 2.5 mL 12 Units
5 mL†
10 Units 3 mL 10 Units
After reconstitution, DYSPORT® should be used for only one injection session and for only one patient. Once reconstituted, DYSPORT® should be stored in the original container, in a refrigerator at 2 °C to8°C (36 °F to 46°F), protected from light for up to 24 hours. It must be discarded if not used within 24 hours. Do not freeze reconstituted DYSPORT®. Discard the vial and needle in accordance with local regulations.

2.2 Dosing in Cervical Dystonia

The recommended initial dose of DYSPORT® for the treatment of cervical dystonia is 500 Units given intramuscularly as a divided dose among affected muscles in patients with or without a history of prior treatment with botulinum toxin. (A description of the average DYSPORT® dose and percentage of total dose injected into specific muscles in the pivotal clinical trials can be found in Table 8 of Section 14.1, Clinical Studies – Cervical Dystonia.) Limiting the dose injected into the sternocleidomastoid muscle may reduce the occurrence of dysphagia. Clinical studies with DYSPORT® in cervical dystonia suggest that the peak effect occurs between two and four weeks after injection. Simultaneous EMG-guided application of DYSPORT® may be helpful in locating active muscles.

Dose Modification

Where dose modification is necessary for the treatment of cervical dystonia, uncontrolled open-label studies suggest that dose adjustment can be made in 250 Unit steps according to the individual patient's response, with re-treatment every 12 weeks or longer, as necessary, based on return of clinical symptoms. Uncontrolled open-label studies also suggest that the total dose administered in a single treatment should be between 250 Units and 1000 Units. Re-treatment, if needed, should not occur in intervals of less than 12 weeks. Doses above 1000 Units have not been systematically evaluated.

Special Populations

Adults and elderly

The starting dose of 500 Units recommended for cervical dystonia is applicable to adults of all ages [see Use in Specific Populations (8.5)].

Pediatric Patients

The safety and effectiveness of DYSPORT® in the treatment in pediatric patients less than 18 years of age has not been assessed [see Warnings and Precautions (5.2)].

Instructions for Preparation and Administration for the Treatment of Cervical Dystonia

DYSPORT® is supplied as a single-use vial. Only use sterile preservative-free 0.9% Sodium Chloride Injection, USP for reconstitution of DYSPORT®. Each 500 Unit vial of DYSPORT® is to be reconstituted with 1 mL of preservative- free 0.9% Sodium Chloride Injection USP to yield a solution of 50 Units per 0.1 mL. Each 300 Unit vial of DYSPORT® is to be reconstituted with 0.6 mL of preservative-free 0.9% Sodium Chloride Injection USP to yield a solution equivalent to 50 Units per 0.1 mL.

Using an appropriately sized sterile syringe, needle and aseptic technique, draw up 1 mL or 0.6 mL of sterile, preservative- free 0.9% Sodium Chloride Injection USP for 500 Unit and 300 Unit vials, respectively. Insert the needle into the DYSPORT® vial. The partial vacuum will begin to pull the saline into the vial. Any remaining required saline should be expressed into the vial manually. Do not use the vial if no vacuum is observed. Swirl gently to dissolve. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Reconstituted DYSPORT® should be a clear, colorless solution, free of particulate matter, otherwise it should not be injected.

Expel any air bubbles in the syringe barrel. Remove the needle used to reconstitute the product and attach an appropriately sized new sterile needle.

Discard the vial and needle in accordance with local regulations.

2.3 Dosing in Glabellar Lines

The dose of DYSPORT® for the treatment of glabellar lines is a total of 50 Units given intramuscularly in five equal aliquots of 10 Units each to achieve clinical effect (see Figure 1).

Special Populations

Adults

A total dose of 50 Units of DYSPORT®, in five equal aliquots, should be administered to achieve clinical effect.

The clinical effect of DYSPORT® may last up to four months. Repeat dose clinical studies demonstrated continued efficacy with up to four repeated administrations. It should be administered no more frequently than every three months. When used for re-treatment, DYSPORT® should be reconstituted and injected using the same techniques as the initial treatment.

Pediatric Patients

DYSPORT® for glabellar lines is not recommended for use in pediatric patients less than 18 years of age [see Warnings and Precautions (5.2)].

Instructions for Preparation and Administration for the Treatment of Glabellar Lines

DYSPORT® is supplied as a single-use vial. Only use sterile preservative-free 0.9% Sodium Chloride Injection, USP for reconstitution of DYSPORT®. Each 300 Unit vial of DYSPORT® is to be reconstituted with 2.5 mL of preservative-free 0.9% Sodium Chloride Injection USP prior to injection. The concentration of the resulting solution will be 10 Units per 0.08 mL (12 Units per 0.1 mL) to be delivered in five equally divided aliquots of 0.08 mL each. DYSPORT® may also be reconstituted with 1.5 mL of preservative-free 0.9% Sodium Chloride Injection USP for a solution of 10 Units per 0.05 mL (20 Units per 0.1 mL) to be delivered in five equally divided aliquots of 0.05 mL each.

Using an appropriately sized sterile syringe, needle and aseptic technique, draw up 2.5 mL or 1.5 mL of preservative- free 0.9% Sodium Chloride Injection USP Insert the needle into the DYSPORT® vial. The partial vacuum will begin to pull the saline into the vial. Any remaining required saline should be expressed into the vial manually. Do not use the vial if no vacuum is observed. Swirl gently to dissolve. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Reconstituted DYSPORT® should be a clear, colorless solution, free of particulate matter otherwise it should not be injected.

Draw a single patient dose of DYSPORT® into a sterile syringe. Expel any air bubbles in the syringe barrel. Remove the needle used to reconstitute the product and attach a 30 gauge needle.

Discard the vial and needle in accordance with local regulations.

Injection Technique

Glabellar facial lines arise from the activity of the lateral corrugator and vertical procerus muscles. These can be readily identified by palpating the tensed muscle mass while having the patient frown. The corrugator depresses the skin creating a "furrowed" vertical line surrounded by tensed muscle (i.e., frown lines). The location, size, and use of the muscles vary markedly among individuals. Physicians administering DYSPORT® must understand the relevant neuromuscular and/or orbital anatomy of the area involved and any alterations to the anatomy due to prior surgical procedures.

Risk of ptosis can be mitigated by careful examination of the upper lid for separation or weakness of the levator palpebrae muscle (true ptosis), identification of lash ptosis, and evaluation of the range of lid excursion while manually depressing the frontalis to assess compensation.

In order to reduce the complication of ptosis, the following steps should be taken:
Avoid injection near the levator palpebrae superioris, particularly in patients with larger brow depressor complexes. Medial corrugator injections should be placed at least 1 centimeter above the bony supraorbital ridge. Ensure the injected volume/dose is accurate and where feasible kept to a minimum. Do not inject toxin closer than 1 centimeter above the central eyebrow.
To inject DYSPORT®, advance the needle through the skin into the underlying muscle while applying finger pressure on the superior medial orbital rim. Inject patients with a total of 50 Units in five equally divided aliquots. Using a 30 gauge needle, inject 10 Units of DYSPORT® into each of five sites, two in each corrugator muscle, and one in the procerus muscle (see Figure 1).

Figure 1

2.4 Dosing in Upper Limb Spasticity

Special Populations

Adults

Dosing in initial and subsequent treatment sessions should be tailored to the individual based on the size, number and location of muscles involved, severity of spasticity, the presence of local muscle weakness, the patient's response to previous treatment, and/or adverse event history with DYSPORT®. In the pivotal clinical trial, doses of 500 Units and 1000 Units were divided among selected muscles, Table 2 and Figure 2, at a given treatment session.

No more than 1 mL should generally be administered at any single injection site.
Table 2: DYSPORT® Dosing by Muscle for Upper Limb Spasticity Muscles Injected Recommended DoseDYSPORT® Recommended Number of Injection(s) per Muscle Flexor carpi radialis (FCR) 100 Units to 200 Units 1 to 2 Flexor carpi ulnaris (FCU) 100 Units to 200 Units 1 to 2 Flexor digitorum profundus (FDP) 100 Units to 200 Units 1 to 2 Flexor digitorum superficialis (FDS) 100 Units to 200 Units 1 to 2 Brachialis 200 Units to 400 Units 1 to 2 Brachioradialis 100 Units to 200 Units 1 to 2 Biceps Brachii (BB) 200 Units to 400 Units 1 to 2 Pronator Teres 100 Units to 200 Units 1
Figure 2: Muscles for Injection for Upper Limb Spasticity

Although actual location of the injection sites can be determined by palpation, the use of injection guiding technique e.g. electromyography, electrical stimulation is recommended to target the injection sites.

Repeat DYSPORT® treatment should be administered when the effect of a previous injection has diminished, but no sooner than 12 weeks after the previous injection. A majority of patients in clinical studies were retreated between 12-16 weeks; however some patients had a longer duration of response, i.e. 20 weeks. The degree and pattern of muscle spasticity at the time of re-injection may necessitate alterations in the dose of DYSPORT® and muscles to be injected. Clinical improvement may be expected one week after administration of DYSPORT®.

Pediatric Patients

The safety and effectiveness of DYSPORT® in the treatment of upper limb spasticity in pediatric patients less than 18 years of age has not been demonstrated. [see Warnings and Precautions (5.2)]

Instructions for Preparation and Administration for the Treatment of Upper Limb Spasticity in Adults

DYSPORT® is supplied as a single-use vial. Only use sterile preservative-free 0.9% Sodium Chloride Injection, USP for reconstitution of DYSPORT®. The recommended concentration is 100 Units/mL or 200 Units/mL with preservative-free 0.9% Sodium Chloride Injection USP) (see Table 1).

Using an appropriately sized sterile syringe, needle and aseptic technique, draw up the required volume (Table 1) of preservative-free 0.9% Sodium Chloride Injection USP.

Insert the needle into the DYSPORT® vial. The partial vacuum will begin to pull the saline into the vial. No more than 2.5 mL of saline should be introduced into the vial (see footnote in Table 1). Do not use the vial if a vacuum is absent. Gently swirl to dissolve. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Reconstituted DYSPORT® should be a clear, colorless solution, free of particulate matter; otherwise it should not be injected. Expel any air bubbles in the syringe barrel. Remove the needle used to reconstitute the product and attach an appropriately sized new sterile needle.

Discard the vial and needle in accordance with local regulations.
Increlex

Increlex

2.1 Dosage

Preprandial glucose monitoring is recommended at treatment initiation and until a well-tolerated dose is established. If frequent symptoms of hypoglycemia or severe hypoglycemia occur, preprandial glucose monitoring should continue. The dosage of INCRELEX® should be individualized for each patient. The recommended starting dose of INCRELEX® is 0.04 to 0.08 mg/kg (40 to 80 micrograms/kg) twice daily by subcutaneous injection. If well-tolerated for at least one week, the dose may be increased by 0.04 mg/kg per dose, to the maximum dose of 0.12 mg/kg given twice daily. Doses greater than 0.12 mg/kg given twice daily have not been evaluated in children with Primary IGFD and, due to potential hypoglycemic effects, should not be used. If hypoglycemia occurs with recommended doses despite adequate food intake, the dose should be reduced. INCRELEX® should be administered shortly before or after (± 20 minutes) a meal or snack. If the patient is unable to eat shortly before or after a dose for any reason, that dose of INCRELEX® should be withheld. Subsequent doses of INCRELEX® should never be increased to make up for one or more omitted dose.

2.2 Administration

INCRELEX® is administered by subcutaneous injection.

INCRELEX® injection sites should be rotated to a different site (upper arm, thigh, buttock or abdomen) with each injection to help prevent lipohypertrophy.

INCRELEX® should be administered using sterile disposable syringes and needles. The syringes should be of small enough volume so that the prescribed dose can be withdrawn from the vial with accuracy.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

If using syringes that measure dose in units, doses in mg/kg must be converted to units using the following formula: Weight (kg) × Dose (mg/kg) × 1 mL/10 mg × 100 units/1 mL = units/injection.
Somatuline Depot

Somatuline Depot

Patients should begin treatment with Somatuline Depot 90 mg given via the deep subcutaneous route, at 4 week intervals for 3 months.

After 3 months dosage may be adjusted as follows:
GH >1 to ≤ 2.5 ng/mL, IGF-1 normal and clinical symptoms controlled: maintain Somatuline Depot dose at 90 mg every 4 weeks. GH > 2.5 ng/mL, IGF-1 elevated and/or clinical symptoms uncontrolled, increase Somatuline Depot dose to 120 mg every 4 weeks. GH ≤ 1 ng/mL, IGF-1 normal and clinical symptoms controlled: reduce Somatuline Depot dose to 60 mg every 4 weeks.
Thereafter, the dose should be adjusted according to the response of the patient as judged by a reduction in serum GH and /or IGF-1 levels; and/or changes in symptoms of acromegaly.

Patients who are controlled on Somatuline Depot 60 mg or 90 mg may be considered for an extended dosing interval of Somatuline Depot 120 mg every 6 or 8 weeks. GH and IGF-1 levels should be obtained 6 weeks after this change in dosing regimen to evaluate persistence of patient response.

Continued monitoring of patients response with dose adjustments for biochemical and clinical symptom control, as necessary, is recommended.

Somatuline Depot should be injected via the deep subcutaneous route in the superior external quadrant of the buttock. The skin should not be folded and the needle should be inserted perpendicular to the skin, rapidly and to its full length. The injection site should alternate between the right and left side.

The starting dose in patients with moderate and severe renal or moderate and severe hepatic impairment should be 60 mg via the deep subcutaneous route, at 4 week intervals for 3 months followed by dose adjustment as described above [see Clinical Pharmacology (12.3)].

Ipsen Biopharmaceuticals, Inc.

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Ipsen Biopharmaceuticals, Inc. Drugs