Triferic
Name: Triferic
Warnings
Contraindications
None
Cautions
Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving parenteral iron products; monitor during and after hemodialysis
Iron status should be determined on predialysis blood samples; postdialysis serum iron parameters may overestimate serum iron and transferrin saturation
How is Triferic (ferric pyrophosphate)given?
Your doctor will perform blood tests to make sure you do not have conditions that would prevent you from safely using ferric pyrophosphate.
Ferric pyrophosphate is added directly to the dialyzer fluid and given during hemodialysis.
A healthcare provider will give you this injection. Ferric pyrophosphate is not for use with home hemodialysis.
You will be watched closely after receiving ferric pyrophosphate, to make sure you do not have an allergic reaction to the medication.
To be sure this medicine is helping your condition, you may need frequent blood tests.
What should I avoid while receiving Triferic (ferric pyrophosphate)?
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
Precautions While Using Triferic
It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to check for unwanted effects.
This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis requires immediate medical attention. Tell your doctor right away if you have a rash, itching, lightheadedness, dizziness, fainting, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are receiving this medicine.
Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant during therapy and for at least 2 weeks after the last dose. If you think you have become pregnant while using the medicine, tell your doctor right away.
What do I need to tell my doctor BEFORE I take Triferic?
- If you have an allergy to Triferic (ferric pyrophosphate citrate) or any part of this medicine.
- If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
This medicine may interact with other drugs or health problems.
Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Triferic with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
What are some things I need to know or do while I take Triferic?
- Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
- Very bad and sometimes deadly allergic reactions have rarely happened. Talk with your doctor.
- Have blood work checked as you have been told by the doctor. Talk with the doctor.
- This medicine may cause harm to the unborn baby if you take it while you are pregnant.
- Use birth control that you can trust to prevent pregnancy while taking Triferic and for at least 2 weeks after stopping the drug.
- If you get pregnant while taking this medicine or within 2 weeks after your last dose, call your doctor right away.
- Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.
How do I store and/or throw out Triferic?
- If you need to store this medicine at home, talk with your doctor, nurse, or pharmacist about how to store it.
Warnings and Precautions
Hypersensitivity Reactions
Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving parenteral iron products. Patients may present with shock, clinically significant hypotension, loss of consciousness, and/or collapse. Monitor patients for signs and symptoms of hypersensitivity during and after hemodialysis until clinically stable. Personnel and therapies should be immediately available for the treatment of serious hypersensitivity reactions [ see Adverse Reactions (6)].
Hypersensitivity reactions have been reported in 1 (0.3%) of 292 patients receiving Triferic in two randomized clinical trials.
Iron Laboratory Testing
Iron status should be determined on pre-dialysis blood samples. Post dialysis serum iron parameters may overestimate serum iron and transferrin saturation.
Clinical Studies
The safety and efficacy of Triferic in patients with HDD-CKD was assessed in two randomized, single blind, placebo-controlled clinical trials. Patients with hemoglobin of 9 g/dL to 12 g/dL with TSAT > 20% and serum ferritin concentrations > 200 mcg/L were enrolled. Patients were to remain in randomized treatment until pre-specified hemoglobin or ferritin criteria were met, indicating the need for a change in anemia management, or if they completed 48 weeks. Triferic was added to the bicarbonate concentrate with a final concentration of 110 mcg iron/L in the dialysate and was administered 3 or 4 times per week during hemodialysis. Most patients were receiving a stable dose of erythropoiesis stimulating agents (ESAs) at baseline. After randomization, patients' ESA doses were not to be changed.
In Study 1, the mean age of patients was 58 years (range 23 to 89); 32% were female, 55% were Caucasian, 32% were African American, and 13% were other races.
In Study 2, the mean age of patients was 58 years (range 20 to 89); 41% were female, 54% were Caucasian, 40% were African American, and 6% were other races.
The primary endpoint of the studies was the mean change in hemoglobin from baseline to the end-of-treatment period (average hemoglobin of the last one-sixth (1/6th) of the time in the randomized treatment period). About 18% of patients completed the planned 48-week treatment duration.
Table 2 shows the mean changes in hemoglobin (Hgb) and iron parameters in each treatment group from baseline to the end-of-treatment period for the ITT population.
| Study 1 | Study 2 | |||
|---|---|---|---|---|
| Triferic n=152 | Placebo n=153 | Triferic n=147 | Placebo n=147 | |
| * p < 0.05 for primary efficacy endpoint | ||||
| Baseline Hemoglobin Mean ± (SD), g/dL | 10.96 (0.592) | 10.91 (0.632) | 10.96 (0.605) | 10.94 (0.622) |
| Hemoglobin, Change from Baseline to End-of-Treatment Mean ± (SD), g/dL | -0.03 (1.147) * | -0.38 (1.240) | -0.08 (1.152) * | -0.44 (1.157) |
| Baseline Ferritin Mean (SD), mcg/L | 508.2 (193.55) | 509.3 (209.06) | 519.0 (201.56) | 478.4 (200.59) |
| Ferritin, Change from Baseline to End-of-Treatment Mean (SD), mcg/L | -70.8 (132.41) | -141.2 (187.74) | -65.3 (162.45) | -120.9 (268.19) |
| Baseline Reticulocyte Hemoglobin (CHr) Mean (SD), pg | 32.37 (1.967) | 32.53 (1.965) | 32.56 (2.210) | 32.57 (1.932) |
| CHr, Change from Baseline to End-of-Treatment Mean (SD), pg | -0.22 (1.191) | -0.90 (1.407) | -0.55 (1.441) | -0.85 (1.474) |
| Baseline TSAT Mean (SD), % | 28.2 (8.23) | 27.1 (7.76) | 28.0 (8.15) | 28.2 (8.52) |
| TSAT, Change from Baseline to End-of-Treatment) Mean (SD), % | -1.0 (9.07) | -2.9 (7.65) | -0.9 (7.54) | -3.6 (7.29) |
How Supplied/Storage and Handling
How Supplied
Triferic is available in ampules or packets in the following package sizes:
| NDC Code | Package Description | Amount/Total Volume in Ampule |
|---|---|---|
| 5 mL Ampule | 27.2 mg iron (III)/ 5mL as Triferic solution (5.44 mg of iron (III) per mL) | |
| NDC 57278-314-01 | 5 Ampules per Pouch | |
| NDC 57278-314-02 | 8 Pouches per Carton | |
| NDC 57278-316-01 | 50 mL Ampule | 272 mg iron (III)/ 50 mL as Triferic solution (5.44 mg of iron (III) per mL) |
| NDC 57278-316-02 | 4 Ampules per Pouch | |
| NDC 57278-316-03 | 6 Pouches per Carton |
| NDC Code | Package Description | Amount/Packet |
|---|---|---|
| NDC 57278-315-01 | Packet | 272 mg iron (III)/ packet as Triferic powder |
| NDC 57278-315-02 | 100 Packets per Carton |
Storage
Store ampules protected from light in the aluminum pouch at controlled room temperature (20° to 25°C [68° to 77°F]); excursions permitted to 15°to 30°C (59° to 86°F) [See USP Controlled Room Temperature].
Store packets at controlled room temperature (20° to 25°C [68° to 77°F]); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].