Gravitate Health FHIR Implementation Guide
0.1.0 - CI Build

Gravitate Health FHIR Implementation Guide, published by Gravitate Health Project. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/hl7-eu/gravitate-health/ and changes regularly. See the Directory of published versions

Example Bundle: bundle-ibrance75-100-125

Composition category:
Composition status: final
Composition type: HUMAN PRESCRIPTION LABEL

SPL PATIENT PACKAGE INSERT SECTION

PATIENT INFORMATION

IBRANCE ® (EYE-brans)
(palbociclib)
Tablets

What is the most important information I should know about IBRANCE?

IBRANCE may cause serious side effects, including:

Low white blood cell counts (neutropenia). Low white blood cell counts are very common when taking IBRANCE and may cause serious infections that can lead to death. Your healthcare provider should check your white blood cell counts before and during treatment.

If you develop low white blood cell counts during treatment with IBRANCE, your healthcare provider may stop your treatment, decrease your dose, or may tell you to wait to begin your treatment cycle. Tell your healthcare provider right away if you have signs and symptoms of low white blood cell counts or infections such as fever and chills.

Lung problems (pneumonitis). IBRANCE may cause severe or life-threatening inflammation of the lungs during treatment that can lead to death. Tell your healthcare provider right away if you have any new or worsening symptoms, including:

  • chest pain
  • cough with or without mucus
  • trouble breathing or shortness of breath

Your healthcare provider may interrupt or stop treatment with IBRANCE completely if your symptoms are severe.

​See "What are the possible side effects of IBRANCE?" for more information about side effects.

What is IBRANCE?

IBRANCE is a prescription medicine used in adults to treat hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer that has spread to other parts of the body (metastatic) in combination with:

  • an aromatase inhibitor as the first hormonal based therapy in postmenopausal women or in men, or
  • fulvestrant in people with disease progression following hormonal therapy.

It is not known if IBRANCE is safe and effective in children.

Before taking IBRANCE, tell your healthcare provider about all of your medical conditions, including if you:

  • have fever, chills, or any other signs or symptoms of infection.
  • have liver or kidney problems.
  • are pregnant, or plan to become pregnant. IBRANCE can harm your unborn baby.
    • Females who are able to become pregnant should use effective birth control during treatment and for at least 3 weeks after the last dose of IBRANCE. Your healthcare provider may ask you to take a pregnancy test before you start treatment with IBRANCE.
    • Males with female partners who can become pregnant should use effective birth control during treatment with IBRANCE for at least 3 months after the last dose of IBRANCE.
    • Talk to your healthcare provider about birth control methods that may be right for you during this time.
    • If you become pregnant or think you are pregnant, tell your healthcare provider right away.
  • are breastfeeding or plan to breastfeed. It is not known if IBRANCE passes into your breast milk. Do not breastfeed during treatment with IBRANCE and for 3 weeks after the last dose.

Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. IBRANCE and other medicines may affect each other causing side effects.

How should I take IBRANCE?

  • Take IBRANCE exactly as your healthcare provider tells you.
  • IBRANCE tablets may be taken with or without food.
  • IBRANCE should be taken at about the same time each day.
  • Swallow IBRANCE tablets whole. Do not chew, crush or split IBRANCE tablets before swallowing them.
  • Do not take any IBRANCE tablets that are broken, cracked, or that look damaged.
  • Avoid grapefruit and grapefruit products during treatment with IBRANCE. Grapefruit may increase the amount of IBRANCE in your blood.
  • Do not change your dose or stop taking IBRANCE unless your healthcare provider tells you.
  • If you miss a dose of IBRANCE or vomit after taking a dose of IBRANCE, do not take another dose on that day. Take your next dose at your regular time.
  • If you take too much IBRANCE, call your healthcare provider right away or go to the nearest hospital emergency room.

What are the possible side effects of IBRANCE?

​IBRANCE may cause serious side effects. See "What is the most important information I should know about IBRANCE?"

The most common side effects of IBRANCE when used with either letrozole or fulvestrant include:

  • Low red blood cell counts and low platelet counts are common with IBRANCE. Call your healthcare provider right away if you develop any of these symptoms during treatment:
    • dizziness
    • shortness of breath
    • weakness
    • bleeding or bruising more easily
    • nosebleeds
  • ​infections (see "What is the most important information I should know about IBRANCE? ")
  • tiredness
  • nausea
  • sore mouth
  • abnormalities in liver blood tests
  • diarrhea
  • hair thinning or hair loss
  • vomiting
  • rash
  • loss of appetite

IBRANCE may cause fertility problems in males. This may affect your ability to father a child. Talk to your healthcare provider about family planning options before starting IBRANCE if this is a concern for you.

These are not all of the possible side effects of IBRANCE.

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 IBRANCE?

  • Store IBRANCE at 68 °F to 77 °F (20 °C to 25 °C) in the original blister pack.

Keep IBRANCE and all medicines out of the reach of children.

General information about the safe and effective use of IBRANCE

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use IBRANCE for a condition for which it was not prescribed. Do not give IBRANCE to other people, even if they have the same symptoms you have. It may harm them. You can ask your pharmacist or healthcare provider for more information about IBRANCE that is written for health professionals.

What are the ingredients in IBRANCE?

Active ingredient: palbociclib

Inactive ingredients: microcrystalline cellulose, colloidal silicon dioxide, crospovidone, magnesium stearate, succinic acid, HPMC 2910/hypromellose, titanium dioxide, triacetin, and FD&C Blue #2/Indigo Carmine Aluminum Lake. In addition, the 75 mg and 125 mg tablets contain red iron oxide and the 100 mg tablets contain yellow iron oxide.

Pfizer Logo

LAB-1372-1.0

For more information, go to www.IBRANCE.com or call 1-800-438-1985.

PRINCIPAL DISPLAY PANEL - TOPPER CARD

Your Monthly Box

Includes 3 weekly packs of 

IBRANCE® (palbociclib) medication.

Fill in the dates below to help track your treatment cycle.

Treatment Cycle

Week 1   Week 2   Week 3

IBRANCE

Week 4

No IBRANCE

My Treatment Cycle Tracker

I start my Week 1 

treatment cycle on: 

________ / ______

MONTH     DAY

After Week 4, I will start my

next treatment cycle on:

________ / ______

MONTH     DAY

PAA119239

TOPPER CARD

PRINCIPAL DISPLAY PANEL - 75 MG TABLET DOSE PACK

Pfizer

NDC 0069-0284-07

IBRANCE® 

(palbociclib)

tablets

75 mg per tablet

This weekly pack contains:

7 tablets

Rx only

75 MG TABLET DOSE PACK

PRINCIPAL DISPLAY PANEL - 75 MG TABLET DOSE PACK CARTON

Pfizer

NDC 0069-0284-03

IBRANCE® 

(palbociclib)

tablets

75 mg

21 tablets

Monthly Box Contains: 3 individual weekly

packs. Each pack contains 7 IBRANCE tablets

(75 mg per tablet).

Rx only

Safety

Label

75 MG TABLET DOSE PACK CARTON

PRINCIPAL DISPLAY PANEL - 100 MG TABLET DOSE PACK

Pfizer

NDC 0069-0486-07

IBRANCE® 

(palbociclib)

tablets

100 mg per tablet

This weekly pack contains:

7 tablets

Rx only

100 MG TABLET DOSE PACK

PRINCIPAL DISPLAY PANEL - 100 MG TABLET DOSE PACK CARTON

Pfizer

NDC 0069-0486-03

IBRANCE® 

(palbociclib)

tablets

100 mg

21 tablets

Monthly Box Contains: 3 individual weekly

packs. Each pack contains 7 IBRANCE tablets

(100 mg per tablet).

Rx only

Safety

Label

100 MG TABLET DOSE PACK CARTON

PRINCIPAL DISPLAY PANEL - 125 MG TABLET DOSE PACK

Pfizer

NDC 0069-0688-07

IBRANCE® 

(palbociclib)

tablets

125 mg per tablet

This weekly pack contains:

7 tablets

Rx only

125 MG TABLET DOSE PACK

PRINCIPAL DISPLAY PANEL - 125 MG TABLET DOSE PACK CARTON

Pfizer

NDC 0069-0688-03

IBRANCE® 

(palbociclib)

tablets

125 mg

21 tablets

Monthly Box Contains: 3 individual weekly

packs. Each pack contains 7 IBRANCE tablets

(125 mg per tablet).

Rx only

Safety

Label

125 MG TABLET DOSE PACK CARTON

IBRANCE® (palbociclib) tablets - 75 mg

NDC: 0069-0284

Full name: IBRANCE® (palbociclib) tablets - 75 mg

Name usage: English (United States of America)

Authorised dose form: Film Coated Tablet Dosage Form

Legal status of supply: Marketing Authorization

Domain: Human

Resource status: Active

Product classification:

  • N0000175605 Kinase Inhibitor [EPC]
  • N0000175082 Kinase Inhibitors [MoA]
  • N0000190114 Cytochrome P450 3A Inhibitors [MoA]

Marketing Authorization 1 of 4

Authorisation number: 0069-0284-03

Region: United States of America

Marketing authorisation holder: Pfizer Laboratories Div Pfizer Inc

Identifier:

  • 134489525

Status: Approved for Human Use Product (2020-03-30T00:00:00Z)

Package 1 of 6

NDC: NDC:0069-0284-03

Description: 3 in 1 CARTON

Marketing status:

  • : Marketing

Pack size:

  • 1

    Package: 1 Carton

    Containing: 3

    Manufactured Item

    Dose form: Film Coated Tablet Dosage Form

    Unit of presentation: Tablet Dosing Unit

    Ingredient

    Role: inactive ingredient

    Substance: CROSPOVIDONE

    Ingredient

    Role: inactive ingredient

    Substance: FD&C BLUE NO. 2 /b>

    Ingredient

    Role: inactive ingredient

    Substance: FERRIC OXIDE RED

    Ingredient

    Role: inactive ingredient

    Substance: HYPROMELLOSE 2910 (6 MPA.S)

    Ingredient

    Role: inactive ingredient

    Substance: MAGNESIUM STEARATE

    Ingredient

    Role: inactive ingredient

    Substance: MICROCRYSTALLINE CELLULOSE

    Ingredient

    Role: active ingredient - basis of strength

    Substance:

    Presentation strength: 75 mg / 1 1

    Ingredient

    Role: inactive ingredient

    Substance: SILICON DIOXIDE

    Ingredient

    Role: inactive ingredient

    Substance: SUCCINIC ACID

    Ingredient

    Role: inactive ingredient

    Substance: 15FIX9V2JP

    Ingredient

    Role: inactive ingredient

    Substance: TRIACETIN

    Package 2 of 6

    NDC: NDC 0069-0284-07

    Description: 7 in 1 DOSE PACK; Type 0: Not a Combination Product

    Marketing status:

    • : Marketing

    Pack size:

    • 1

      Package: 1 Dose Pack

      Containing: 7

      Manufactured Item

      Dose form: Film Coated Tablet Dosage Form

      Unit of presentation: Tablet Dosing Unit

      Ingredient

      Role: inactive ingredient

      Substance: CROSPOVIDONE

      Ingredient

      Role: inactive ingredient

      Substance: FD&C BLUE NO. 2 /b>

      Ingredient

      Role: inactive ingredient

      Substance: FERRIC OXIDE RED

      Ingredient

      Role: inactive ingredient

      Substance: HYPROMELLOSE 2910 (6 MPA.S)

      Ingredient

      Role: inactive ingredient

      Substance: MAGNESIUM STEARATE

      Ingredient

      Role: inactive ingredient

      Substance: MICROCRYSTALLINE CELLULOSE

      Ingredient

      Role: active ingredient - basis of strength

      Substance:

      Presentation strength: 75 mg / 1 1

      Ingredient

      Role: inactive ingredient

      Substance: SILICON DIOXIDE

      Ingredient

      Role: inactive ingredient

      Substance: SUCCINIC ACID

      Ingredient

      Role: inactive ingredient

      Substance: 15FIX9V2JP

      Ingredient

      Role: inactive ingredient

      Substance: TRIACETIN

      Administrable Product (1 of 3)

      Dose form: Film Coated Tablet Dosage Form

      Unit of presentation: Tablet Dosing Unit

      Route of administration:

      • Oral Route of Administration

      Ingredients: