standard Signifor LAR Injection growing older
Photo :Signifor LAR Injection step by step [lower:<0.01 for treatment difference & The maximum dose approved for use in the United States was not used in this trial but the majority of patients were receiving the dose most commonly used in the United States to treat acromegaly SIGNIFOR LAR (40 60mg) N=176 Active Comparator & N=182 GH> <2.5mcg/L and normalized IGF-1* 31.3%** 19.2% GH> <2.5mcg/L and IGF-1>
<2.5 mcg/L 48.3% 51.6% Figure 3: Mean GH (mcg/L) Levels by Visit in Drug Naïve Patient Study* * Numbers of patients with a GH value at the given timepoint for Signifor LAR/Active comparator arm are displayed as xxx/xxx on the x axis. Figure 4: Mean Standardized IGF-1 Levels* by Visit in Drug Naïve Patient Study** ** Numbers of patients with an IGF-1 value at the given timepoint for Signifor LAR/Active comparator arm are displayed as xxx/xxx on the x axis. Biochemical control was achieved by Month 3 in 30.1% of patients in the SIGNIFOR LAR arm. Ninety-eight percent of patients treated with SIGNIFOR LAR had either a reduction or no change in tumor volume from baseline assessed by MRI at month 12. The median (range) change in tumor volume was a reduction of 39.8% (-97.6% to 16.9%). Additionally, ring size and acromegaly symptoms score (i.e. headache, fatigue, perspiration, paresthesia, and osteoarthralgia) were followed. At month 12, reductions in ring size and in symptom severity scores in both treatment groups compared to baseline were noted. Patients with Acromegaly Inadequately Controlled on Other Somatostatin Analogs A multicenter, randomized, 3-arm trial was conducted in patients with acromegaly inadequately controlled on somatostatin analogs. Patients were randomized to double-blind SIGNIFOR LAR 40 mg (n=65) or SIGNIFOR LAR 60 mg (n=65) or to continued open-label pre-trial somatostatin analog therapies at maximal or near maximal doses (n=68). A total of 181 patients completed the 6 month trial. Inadequate control was defined as a GH concentration of greater than 2.5 mcg/L (i.e., mean of 5 samples over 2 hours) and a sex- and age-adjusted IGF-1 level greater than 1.3 times the upper limit of normal. Patients were required to have been treated with other somatostatin analogs for at least 6 months prior to randomization. Note that the maximum dose for one of the active comparators approved for use in the United States was not used in this multinational trial; approximately 75% of the population in the comparator group was receiving this active comparator. In the overall study population, 56% were female and the average age of patients was 45 years. Eighty-one percent of patients were Caucasian, 7% Other, 8% Black, 2% American Indian and 2% Asian. The percentage of patients with previous pituitary surgery in the SIGNIFOR LAR 40 mg and 60 mg arms and in the active control arm was 77%, 63% and 60%, respectively. Three percent (3%) of patients in the SIGNIFOR LAR groups and 7% of patients in the active control arm had prior radiation therapy. Median (range) time from diagnosis to participation in this trial was 50 (10 337) months, 55 (8 357) months, and 54 (8 357) months in the SIGNIFOR LAR 40 mg, 60 mg and the pre-trial therapy arms, respectively. At baseline, median (range) GH was 7.1 (1.0 200) mcg/L, 5.3 (1.4 113.8) mcg/L and 6.1 (1.0 92.4) mcg/L in the SIGNIFOR LAR 40 mg, 60 mg and the pre-trial therapy arms, respectively. Baseline median standardized IGF-1 (defined as IGF-1 value divided by the ULN) values were 2.3, 2.6 and 2.9 in the SIGNIFOR LAR 40 mg, 60 mg and the pre-trial therapy arms, respectively. The efficacy endpoint was the proportion of patients with a mean GH level less than 2.5 mcg/L and normal IGF-1 levels at week 24. The primary analysis compared SIGNIFOR LAR 60 mg and 40 mg to continued pre-trial therapy (i.e., no change in treatment). The proportion of patients achieving biochemical control was 15.4% and 20.0% for SIGNIFOR LAR 40 mg and 60 mg, respectively, at 6 months. Biochemical control was achieved by Month 3 in 15.4% and 18.5% of patients in the SIGNIFOR LAR 40 mg and 60 mg arms, respectively. Table 5 Results at 6 Months in Inadequately Controlled Patient Study * Primary endpoint (patients with IGF-1> < lower limit of normal (LLN) were not considered as responders ). & For one of the active comparators, the maximum dose approved for use in the United States was not used in this trial but the majority of patients were receiving the dose most commonly used in the United States to treat acromegaly. SIGNIFOR LAR 40 mg N=65 SIGNIFOR LAR 60 mg N=65 Continued Pre-Trial Therapy Control Arm & N=68 GH <2.5 mcg /L and normalized IGF-1* 15.4% 20.0% 0% Normalization of IGF-1 24.6% 26.2% 0% GH> <2.5 mcg /L 35.4% 43.1% 13.2% Eighty-one percent and 70 percent of patients treated with SIGNIFOR LAR 40 mg and 60 mg, respectively, had either a reduction or no change in tumor volume from baseline assessed by MRI at month 6. The median (range) change in tumor volume was a reduction of -10.4% (-74.5% to 19.4%) and -6.3% (-66.7% to 14.5%) from baseline for SIGNIFOR LAR 40 mg and 60 mg, respectively. HOW SUPPLIED/STORAGE AND HANDLING How Supplied SIGNIFOR LAR (pasireotide) for injectable suspension is supplied in a single-use kit containing the following: One 6-mL brownish glass vial with a grey rubber stopper of SIGNIFOR LAR containing slightly yellow to yellow powder capped with 20 mg (gray flip-off cap), 40 mg (red flip-off cap), or 60 mg (orange flip-off cap) One 3-mL glass barrel/grey rubber stopper prefilled syringe containing 2 mL of clear, colorless to slightly yellow/brown diluent solution for reconstitution One sterile 20G x 1.5 stainless steel, polypropylene safety injection needle One vial adapter made of polycarbonate for drug product reconstitution After reconstitution of the 20 mg, 40 mg, or 60 mg SIGNIFOR LAR vials with the provided 2 mL diluent, the injectable suspension will have a final concentration of 10 mg/mL, 20 mg/mL and 30 mg/mL and should be delivered in its entirety. Drug Product Kits: 20 mg kit NDC 0078-0641-81 40 mg kit NDC 0078-0642-81 60 mg kit NDC 0078-0643-81 Storage and Handling Store at 2 C 8 C (36 F 46 F). Do not freeze. SIGNIFOR LAR should be stored at refrigerated temperatures between 2 C 8 C (36 F 46 F) until the time of use. SIGNIFOR LAR drug product kit should remain at room temperature for a minimum of 30 minutes before reconstitution, but should not exceed 24 hours at room temperature. However, after preparation of the drug suspension, it must be administered immediately. PATIENT COUNSELING INFORMATION See FDA-approved patient labeling (Patient Information) . Counsel patients on the following possible significant adverse reactions: Hyperglycemia and Diabetes [see Warnings and Precautions (5.1)] Bradycardia and QT Prolongation [see Warnings and Precautions (5.2)] Liver Test Elevations [see Warnings and Precautions (5.3)] Cholelithiasis [see Warnings and Precautions (5.4)] Pituitary Hormone Deficiency(ies) [see Warnings and Precautions (5.5)] Instruct patients on the importance of adhering to their return visit schedule. Advise patients that SIGNIFOR LAR should only be administered by a trained health care professional. Manufactured by: Novartis Pharma AG Basel, Switzerland Distributed by: Novartis Pharmaceuticals Corporation East Hanover, NJ 07936 T2014-109 Patient Information SIGNIFOR LAR (sig-na-for L.A.R.) (pasireotide) for injectable suspension, for intramuscular use Read this Patient Information before you start receiving SIGNIFOR LAR, and each time you receive it. There may be new information. This leaflet does not take the place of talking to your healthcare provider about your medical condition or your treatment. What is SIGNIFOR LAR? SIGNIFOR LAR is a prescription medicine used to treat people with acromegaly for whom surgery has not worked well enough or who cannot have surgery. It is not known if SIGNIFOR LAR is safe and effective for use in children. What should I tell my healthcare provider before receiving SIGNIFOR LAR? Before you receive SIGNIFOR LAR, tell your healthcare provider if you: have high blood sugar (hyperglycemia) have diabetes have or have had heart problems, including an abnormal heart rate or rhythm or problems with the electrical system of your heart (QT prolongation) have a low level of potassium or magnesium in your blood have liver problems have gallstones (cholelithiasis) have any other medical conditions are pregnant or planning to become pregnant. SIGNIFOR LAR may harm your unborn baby. are breastfeeding or planning to breastfeed. It is not known if SIGINFOR LAR passes into your breast milk. You and your healthcare provider should decide if you will receive SIGNIFOR LAR or breastfeed. You should not do both. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. SIGNIFOR LAR and other medicines may affect each other, causing side effects. SIGNIFOR LAR may affect the way other medicines work, and other medicines may affect how SIGNIFOR LAR works. Your healthcare provider may need to change your dose of SIGNIFOR LAR. Especially tell your healthcare provider if you take: medicines to control your heart beat (anti-arrhythmics) medicines to control your blood pressure (such as beta-blockers or calcium channel blockers) medicines to control the potassium and magnesium (electrolytes) levels in your body medicines that may affect the way the electrical system of your heart works (QT prolongation) cyclosporine bromocriptine Ask your healthcare provider for a list of these medicines if you are not sure. Know the medicines you take. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine. How will I receive SIGNIFOR LAR? SIGNIFOR LAR must be given by a trained healthcare provider as an injection into the muscle of your buttocks (intramuscularly). Your healthcare provider will tell you how much SIGNIFOR LAR you will receive and when you will receive it. Your healthcare provider may change your dose of SIGNIFOR LAR or the length of time between your injections. Your healthcare provider will tell you how long you need to receive SIGNIFOR LAR. Before you receive SIGNIFOR for the first time, your healthcare provider should do a blood test to check your fasting blood sugar level, electrolyte levels, and your liver function. Before you receive SIGNIFOR LAR for the first time and during your treatment, your healthcare provider should do a test to check your heart (electrocardiogram). What are the possible side effects of SIGNIFOR LAR? SIGNIFOR LAR may cause serious side effects, including: high blood sugar (hyperglycemia) and diabetes. Your healthcare provider should check your blood sugar level before you start receiving SIGNIFOR LAR and while you receive it. Tell your healthcare provider if you have any of these symptoms: feel very thirsty urinate more than usual increased appetite with weight loss tiredness If you get hyperglycemia while receiving SIGNIFOR LAR, your healthcare provider may give you another medicine to lower your blood sugar. Your healthcare provider may also change your dose of SIGNIFOR LAR or advise you to stop receiving it. slow heart rate (bradycardia). SIGNIFOR LAR can cause your heart to beat slower. People who have, or have had heart problems, or take certain medicines used to treat slow heart rate or that may cause a slow heart rate, are at higher risk for bradycardia. Tell your healthcare provider if you get any of these symptoms: weakness dizziness fainting or near fainting spells changes in the electrical system of your heart (QT interval prolongation). Tell your healthcare provider if you get any of these symptoms: weakness dizziness fainting or near fainting spells higher than normal liver function tests. Your healthcare provider should do blood tests to check your liver while you receive SIGNIFOR LAR. gallstones (cholelithiasis). Tell your healthcare provider if you get any of these symptoms: sudden pain in your upper right stomach area (abdomen) sudden pain in your right shoulder or between your shoulder blades yellowing of your skin and whites of your eyes fever with chills nausea low levels of pituitary hormones (pituitary insufficiency). SIGNIFOR LAR may reduce the pituitary hormones in your body. Your healthcare provider should do a blood test to check your pituitary hormone levels before you start receiving SIGNIFOR LAR and while you receive it. Tell your healthcare provider if you get any of these symptoms: nausea and vomiting tiredness dizziness diarrhea low blood glucose levels loss of appetite weight loss The most common side effects of SIGNIFOR LAR include: diarrhea gallstones (cholelithiasis) high blood sugar (hyperglycemia) diabetes mellitus Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of SIGNIFOR LAR. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1 800 FDA 1088. How should I store SIGNIFOR LAR? Store SIGNIFOR LAR in the refrigerator between 36OF to 46OF (2OC to 8OC). Take SIGNIFOR LAR out of the refrigerator at least 30 minutes before you will receive it to allow it to come to room temperature. Do not use SIGNIFOR LAR if it has been out of the refrigerator and at room temperature for more than 24 hours. Your healthcare provider should give you SIGNIFOR LAR right away after it is mixed. Keep SIGNIFOR LAR and all medicines out of the reach of children. General information about the safe and effective use of SIGNIFOR LAR. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use SIGNIFOR LAR for a condition for which it was not prescribed. Do not give SIGNIFOR LAR to other people, even if they have the same symptoms that you have. It may harm them. This Patient Information leaflet summarizes the most important information about SIGNIFOR LAR. If you would like more information, talk to your healthcare provider. You can ask your pharmacist or healthcare provider for information about SIGNIFOR LAR that is written for health professionals. For more information go to www.SIGNIFORLAR.com or call1-888-NOW-NOVA. What are the ingredients in SIGNIFOR LAR? Active ingredient: pasireotide Inactive ingredients: Vial: (D,L-lactide-co-glycolide) Prefilled syringe: Mannitol, carboxymethylcellulose sodium, poloxamer 188, water for injections This Patient Information has been approved by the U.S. Food and Drug Administration. Manufactured by: Novartis Pharma AG, Basel, Switzerland Issued: 12/2014 T2014-110 December 2014 PRINCIPAL DISPLAY PANEL Package Label 20 mg Rx Only NDC 0078-0641-81 Signifor LAR (pasireotide) For Injectable Suspension For Intramuscular Use PRINCIPAL DISPLAY PANEL Package Label 40 mg Rx Only NDC 0078-0642-81 Signifor LAR (pasireotide) For Injectable Suspension For Intramuscular Use PRINCIPAL DISPLAY PANEL Package Label 60 mg Rx Only NDC 0078-0643-81 Signifor LAR (pasireotide) For Injectable Suspension For Intramuscular Use SIGNIFOR LAR pasireotide kit Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0078-0641 Packaging # Item Code Package Description 1 NDC:0078-0641-81 1 VIAL, SINGLE-USE in 1 KIT 1 NDC:0078-0641-61 1 KIT in 1 VIAL, SINGLE-USE Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 VIAL, SINGLE-USE 6 mL Part 2 1 SYRINGE 2 mL Part 1 of 2 SIGNIFOR LAR pasireotide injection, powder, for suspension Product Information Route of Administration INTRAMUSCULAR DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PASIREOTIDE (PASIREOTIDE) PASIREOTIDE 10 mg in 1 mL Inactive Ingredients Ingredient Name Strength POLY(DL-LACTIC-CO-GLYCOLIC ACID), (50:50; 63000 MW) POLY(DL-LACTIC-CO-GLYCOLIC ACID), (50:50; 12000 MW) Packaging # Item Code Package Description 1 6 mL in 1 VIAL, SINGLE-USE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA203255 12/15/2014 Part 2 of 2 DILUENT diluent injection, solution Product Information Route of Administration INTRAMUSCULAR DEA Schedule Inactive Ingredients Ingredient Name Strength MANNITOL 45 mg in 1 mL CARBOXYMETHYLCELLULOSE SODIUM 7 mg in 1 mL POLOXAMER 188 2 mg in 1 mL WATER 1 mL in 1 mL Packaging # Item Code Package Description 1 2 mL in 1 SYRINGE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA203255 12/15/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA203255 12/15/2014 SIGNIFOR LAR pasireotide kit Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0078-0642 Packaging # Item Code Package Description 1 NDC:0078-0642-81 1 VIAL, SINGLE-USE in 1 KIT 1 NDC:0078-0642-61 1 KIT in 1 VIAL, SINGLE-USE Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 VIAL, SINGLE-USE 6 mL Part 2 1 SYRINGE 2 mL Part 1 of 2 SIGNIFOR LAR pasireotide injection, powder, for suspension Product Information Route of Administration INTRAMUSCULAR DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PASIREOTIDE (PASIREOTIDE) PASIREOTIDE 20 mg in 1 mL Inactive Ingredients Ingredient Name Strength POLY(DL-LACTIC-CO-GLYCOLIC ACID), (50:50; 63000 MW) POLY(DL-LACTIC-CO-GLYCOLIC ACID), (50:50; 12000 MW) Packaging # Item Code Package Description 1 6 mL in 1 VIAL, SINGLE-USE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA203255 12/15/2014 Part 2 of 2 DILUENT diluent injection, solution Product Information Route of Administration INTRAMUSCULAR DEA Schedule Inactive Ingredients Ingredient Name Strength MANNITOL 45 mg in 1 mL CARBOXYMETHYLCELLULOSE SODIUM 7 mg in 1 mL POLOXAMER 188 2 mg in 1 mL WATER 1 mL in 1 mL Packaging # Item Code Package Description 1 2 mL in 1 SYRINGE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA203255 12/15/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA203255 12/15/2014 SIGNIFOR LAR pasireotide kit Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0078-0643 Packaging # Item Code Package Description 1 NDC:0078-0643-81 1 VIAL, SINGLE-USE in 1 KIT 1 NDC:0078-0643-61 1 KIT in 1 VIAL, SINGLE-USE Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 VIAL, SINGLE-USE 6 mL Part 2 1 SYRINGE 2 mL Part 1 of 2 SIGNIFOR LAR pasireotide injection, powder, for suspension Product Information Route of Administration INTRAMUSCULAR DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PASIREOTIDE (PASIREOTIDE) PASIREOTIDE 30 mg in 1 mL Inactive Ingredients Ingredient Name Strength POLY(DL-LACTIC-CO-GLYCOLIC ACID), (50:50; 63000 MW) POLY(DL-LACTIC-CO-GLYCOLIC ACID), (50:50; 12000 MW) Packaging # Item Code Package Description 1 6 mL in 1 VIAL, SINGLE-USE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA203255 12/15/2014 Part 2 of 2 DILUENT diluent injection, solution Product Information Route of Administration INTRAMUSCULAR DEA Schedule Inactive Ingredients Ingredient Name Strength MANNITOL 45 mg in 1 mL CARBOXYMETHYLCELLULOSE SODIUM 7 mg in 1 mL POLOXAMER 188 2 mg in 1 mL WATER 1 mL in 1 mL Packaging # Item Code Package Description 1 2 mL in 1 SYRINGE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA203255 12/15/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA203255 12/15/2014 Labeler - Novartis Pharmaceuticals Corporation (002147023) Revised: 12/2014 Novartis Pharmaceuticals Corporation Next Interactions Print this page Add to My Med List More about Signifor LAR (pasireotide) Side Effects During Pregnancy Dosage Information Drug Interactions Support Group Pricing & Coupons En Español 0 Reviews Add your own review/rating Drug class: somatostatin and somatostatin analogs Consumer resources Signifor LAR Signifor LAR (Advanced Reading) Professional resources Pasireotide (AHFS Monograph) Other brands: Signifor Related treatment guides Acromegaly> ]} FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only C Pregnancy Category Risk cannot be ruled out N/A CSA Schedule Not a controlled drug Manufacturer Novartis Pharmaceuticals Corporation Drug Class Somatostatin and somatostatin analogs Related Drugs somatostatin and somatostatin analogs octreotide , Sandostatin , lanreotide , Somatuline Depot , Signifor , Sandostatin LAR Depot Acromegaly octreotide , Sandostatin , bromocriptine , Parlodel , lanreotide , Somatuline Depot , Sandostatin LAR Depot , Somavert , pegvisomant , pasireotide , More... Signifor LAR Rating No Reviews - Be the first! No Reviews - Be the first! Not Rated - Be the first!} } of what's
aside from Signifor LAR Injection appears to be
EmoticonEmoticon