Kepivance (Page 4 of 4)


1
WHO Oral Mucositis Scale: Grade 1 = soreness/erythema; Grade 2 = erythema, ulcers, can eat solids; Grade 3 = ulcers, requires liquid diet only; Grade 4 = alimentation not possible.

14.2 Lack of Efficacy: Autologous transplantation preparative regimen using high dose melphalan

In a post approval study, Study 3, designed to determine the efficacy of Kepivance with a high dose melphalan preparative regimen, patients with multiple myeloma were evaluated in a multicenter, randomized, double-blind, placebo-controlled trial. The conditioning regimen was melphalan (200 mg/m 2) on day -2 followed by autologous hematopoietic stem cell support. A total of 281 patients were randomized to 3 arms: Kepivance before melphalan on days -6, -5, -4 and after melphalan on days 0, 1, and 2 (pre-post) (n=115); Kepivance before melphalan on days -6, -5, -4 (pre) (n=109); or placebo (n=57).

The main outcome of the study was maximum severity of WHO oral mucositis. The median age of enrolled patients was 57 years (range 32-69), and 55% were male. The results are presented in Figure 2. The prespecified primary analysis was a comparison between the Kepivance pre-post and pre arms to placebo. The incidence of WHO Grade 3 and 4 in the Kepivance pre-post arm was 38%, compared to 37% in the placebo arm. There were no significant differences between either of the Kepivance regimens and the placebo arm in the incidence of severe oral mucositis.

Figure 2: Incidence of Oral Mucositis by Maximum Grade WHO Oral Mucositis Scale in High Dose Melphalan Study

Figure 2
(click image for full-size original)

A subset of subjects enrolled in the multiple myeloma study were included in an evaluation for the risk of cataract development in patients receiving Kepivance treatment. Ophthalmologic examinations were performed on 101 patients enrolled in a double-blind, randomized, placebo-controlled study of two different schedules of Kepivance (pre and post chemotherapy and pre chemotherapy only) for reduction in severity of oral mucositis in subjects with multiple myeloma receiving high dose melphalan followed by autologous peripheral blood stem cell transplantation. For the primary cataract endpoint of incidence of cataract development or cataract progression at Month 12, there was a greater proportion of subjects that experienced cataract development in the Kepivance group: 48% (25/52) compared with the placebo group: 29% (4/14) (difference of 17 [95% CI: -11, 46]) [see Adverse Reactions ( 6.1)] .

14.3 Lack of Efficacy: Allogeneic Transplantation

In a post approval study, designed to determine the efficacy of Kepivance in decreasing the incidence of severe acute graft versus host disease (aGVHD) in patients with hematologic malignancies undergoing allogeneic transplantation, the incidence, duration and severity of oral mucositis was also measured. Multiple conditioning regimens were used. Patients were randomized to placebo (n=78) or to Kepivance (n=77) 60 micrograms/kg for 3 doses prior to the conditioning regimen and 180 micrograms/kg at least 24 hours from the last dose of chemotherapy and at least 24 hours before the first dose of post transplant methotrexate. There was no difference in the incidence of severe aGVHD Kepivance (16%) compared to placebo (17%). In addition to the lack of efficacy in preventing severe aGVHD, the incidence of WHO grade 3 and 4 mucositis was nominally higher in patients treated with Kepivance (81%) compared to placebo (73%).

16 HOW SUPPLIED/STORAGE AND HANDLING

Kepivance is supplied as a lyophilized powder in single-dose vials containing 6.25 mg of palifermin.

Kepivance vials are supplied in:

  • a dispensing pack containing 3 vials (NDC 66658-112-03)
  • a dispensing pack containing 6 vials (NDC 66658-112-06)

Store Kepivance vials in the dispensing pack in its carton refrigerated at 2° to 8°C (36° to 46°F) until time of use. Protect from light.

17 PATIENT COUNSELING INFORMATION

Advise patients to report the following to healthcare providers:

  • Rashes and reddening of skin [see Adverse Reactions ( 6.1)]
  • Itchiness [see Adverse Reactions ( 6.1)]
  • Swelling of tongue [see Adverse Reactions ( 6.1)]
  • Changes in mouth and tongue sensation [see Adverse Reactions ( 6.1)]
  • Alteration in taste [see Adverse Reactions ( 6.1)]

Inform patients

  • That the safety and efficacy of Kepivance have not been established in patients with non-hematologic malignancies [see Indications and Usage ( 1) and Warnings and Precautions ( 5.1)]
  • Of the evidence of tumor growth and stimulation in cell culture and in animal models of non-hematopoietic human tumors [see Warnings and Precautions ( 5.1) and Clinical Pharmacology ( 12.1)]

sobi
SWEDISH ORPHAN BIOVITRUM
Manufactured by
:
Swedish Orphan Biovitrum AB (publ)
SE-112 76 Stockholm, Sweden
U.S. License No. 1859

© Swedish Orphan Biovitrum AB (publ). All rights reserved.

Principal Display Panel — 6.25 mg/1.2 mL Carton Label

6 x 6.25 mg/vial Single Use Vials

sobi

Kepivance ® (palifermin)

For Injection

6.25 mg/vial

Dosage — See Package Insert

No U.S. Standard of Potency

US Patent Numbers:

6,420,531 B1; 5,824,643; and 5,677,278

Principal Display Panel -- 6.25 mg/1.2 mL Carton Label
(click image for full-size original)

Principal Display Panel — 6.25 mg/1.2 mL Carton Label

3 x 6.25 mg/vial Single Use Vials

sobi

Kepivance ® (palifermin)

For Injection

6.25 mg/vial

Dosage — See Package Insert

No U.S. Standard of Potency

US Patent Numbers:

6,420,531 B1; 5,824,643; and 5,677,278

Principal Display Panel -- 6.25 mg/1.2 mL Carton Label
(click image for full-size original)
KEPIVANCE palifermin injection, powder, lyophilized, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66658-112
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PALIFERMIN (PALIFERMIN) PALIFERMIN 6.25 mg in 1.2 mL
Inactive Ingredients
Ingredient Name Strength
MANNITOL 50 mg in 1.2 mL
SUCROSE 25 mg in 1.2 mL
HISTIDINE 1.94 mg in 1.2 mL
POLYSORBATE 20 0.13 mg in 1.2 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66658-112-24 4 CARTON in 1 BOX contains a CARTON (66658-112-06)
1 NDC:66658-112-06 6 VIAL, SINGLE-USE in 1 CARTON This package is contained within the BOX (66658-112-24) and contains a VIAL, SINGLE-USE (66658-112-01)
1 NDC:66658-112-01 1.2 mL in 1 VIAL, SINGLE-USE This package is contained within a CARTON (66658-112-06) and a BOX (66658-112-24)
2 NDC:66658-112-06 6 VIAL, SINGLE-USE in 1 CARTON contains a VIAL, SINGLE-USE (66658-112-01)
2 NDC:66658-112-01 1.2 mL in 1 VIAL, SINGLE-USE This package is contained within the CARTON (66658-112-06)
3 NDC:66658-112-03 3 VIAL, SINGLE-USE in 1 CARTON contains a VIAL, SINGLE-USE (66658-112-01)
3 NDC:66658-112-01 1.2 mL in 1 VIAL, SINGLE-USE This package is contained within the CARTON (66658-112-03)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125103 12/15/2009
Labeler — Swedish Orphan Biovitrum AB (publ) (354010589)

Revised: 04/2020 Swedish Orphan Biovitrum AB (publ)

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